Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications

---
identifier: "/us/fr/2018-25071"
source: "fr"
legal_status: "authoritative_unofficial"
title: "Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications"
title_number: 0
title_name: "Federal Register"
section_number: "2018-25071"
section_name: "Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications"
positive_law: false
currency: "2018-11-16"
last_updated: "2018-11-16"
format_version: "1.1.0"
generator: "[email protected]"
agency: "Health and Human Services Department"
document_number: "2018-25071"
document_type: "notice"
publication_date: "2018-11-16"
agencies:
  - "Health and Human Services Department"
  - "Food and Drug Administration"
fr_citation: "83 FR 57730"
fr_volume: 83
docket_ids:
  - "Docket Nos. FDA-2017-M-6970, FDA-2017-M-6971, FDA-2017-M-6983, FDA-2017-M-6984, FDA-2017-M-7004, FDA-2018-M-0411, FDA-2018-M-0528, FDA-2018-M-0620, FDA-2018-M-0736, FDA-2018-M-0737, FDA-2018-M-00-0738, FDA-2018-M-0792, FDA-2018-M-1371, FDA-2018-M-1215, FD"
fr_action: "Notice."
---


#  Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications

**AGENCY:**

Food and Drug Administration, HHS.

**ACTION:**

Notice.

**SUMMARY:**

The Food and Drug Administration (FDA) is publishing a list of premarket approval applications (PMAs) and humanitarian device exemption applications (HDEs), that have been approved. This list is intended to inform the public of the availability of safety and effectiveness summaries of approved PMAs through the internet and the Agency's Dockets Management Staff.

**ADDRESSES:**

You may submit comments as follows:

**Electronic Submissions**

Submit electronic comments in the following way:

• *Federal eRulemaking Portal: https://www.regulations.gov.* Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to *https://www.regulations.gov* will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on *https://www.regulations.gov.*

• If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).

**Written/Paper Submissions**

Submit written/paper submissions as follows:

• *Mail/Hand Delivery/Courier (for written/paper submissions):* Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

• For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”

*Instructions:* All submissions received must include the Docket Nos. FDA-2017-M-6970, FDA-2017-M-6971, FDA-2017-M-6983, FDA-2017-M-6984, FDA-2017-M-7004, FDA-2018-M-0411, FDA-2018-M-0528, FDA-2018-M-0620, FDA-2018-M-0736, FDA-2018-M-0737, FDA-2018-M-00-0738, FDA-2018-M-0792, FDA-2018-M-1371, FDA-2018-M-1215, FDA-2018-M-1237, FDA-2018-M-1372, FDA-2018-M-1446, FDA-2018-M-1447, FDA-2018-M-1580, FDA-2018-M-1581, FDA-2018-M-1634, FDA-2018-M-1727, FDA-2018-M-1791, FDA-2018-M-1753, FDA-2018-M-1970, FDA-2018-M-2118, FDA-2018-M-2119, FDA-2018-M-2237, FDA-2018-M-2269, FDA-2018-M-2335, FDA-2018-M-2460, FDA-2018-M-2461, FDA-2018-M-2462, FDA-2018-M-2463, FDA-2018-M-2571, FDA-2018-M-2883, FDA-2018-M-2884, FDA-2018-M-2885, FDA-2018-M-2886, FDA-2018-M-2887, FDA-2018-M-2983, FDA-2018-M-3131, FDA-2018-M-3153, FDA-2018-M-3212, FDA-2018-M-3503, FDA-2018-M-3505, and FDA-2018-M-3548 for “Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications.” Received comments will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at *https://www.regulations.gov* or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday.

• Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on *https://www.regulations.gov.* Submit both copies to the Dockets Management Staff. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as “confidential.” Any information marked as “confidential” will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: *https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf* .

*Docket:* For access to the docket to read background documents or the electronic and written/paper comments received, go to *https://www.regulations.gov* and insert the docket number, found in brackets in the heading of this document, into the “Search” box and follow the prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

**FOR FURTHER INFORMATION CONTACT:**

Joshua Nipper, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 1650, Silver Spring, MD 20993-0002, 301-796-6524.

**SUPPLEMENTARY INFORMATION:**

**I. Background**

In accordance with section 515(d)(4) and (e)(2) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360e(d)(4) and (e)(2)), notification of an order approving, denying, or withdrawing approval of a PMA will continue to include a notice of opportunity to request review of the order under section 515(g) of the FD&C Act. The 30-day period for requesting reconsideration of an FDA action under § 10.33(b) (21 CFR 10.33(b)) for notices announcing approval of a PMA begins on the day the notice is placed on the internet. Section 10.33(b) provides that FDA may, for good cause, extend this 30-day period. Reconsideration of a denial or withdrawal of approval of a PMA may be sought only by the applicant; in these cases, the 30-day period will begin when the applicant is notified by FDA in writing of its decision.

The regulations provide that FDA publish a list of available safety and effectiveness summaries of PMA approvals and denials that were announced during that quarter. The following is a list of approved PMAs for which summaries of safety and effectiveness were placed on the internet from January 1, 2018, through September 18, 2018. There were no denial actions during this period. The list provides the manufacturer's name, the product's generic name or the trade name, and the approval date.

| PMA No., Docket No. | Applicant | Trade name | Approval date |
| --- | --- | --- | --- |
| P150005/S014, FDA-2017-M-6970 | Boston Scientific | Blazer® Open-Irrigated Ablation Catheter and IntellaNav
                            
                             Open-Irrigated Ablation Catheter | 12/21/2017 |
| P100030/S008, FDA-2017-M-6971 | Mallinckrodt Pharma IP Trading DAC | PREVELEAK Surgical Sealant | 12/21/2017 |
| P160012, FDA-2017-M-6983 | Physio-Control, Inc | LIFEPAK CR® Plus Defibrillator, LIFEPAK EXPRESS® Defibrillator and CHARGE-PAK® Battery Charger | 12/21/2017 |
| P140032, FDA-2017-M-6984 | Medtronic, Inc | Implantable System for Remodulin® | 12/22/2017 |
| P160022, FDA-2017-M-7004 | ZOLL Medical Corp | X Series®, R Series®, AED Pro®, and AED 3
                            
                             BLS® Professional Defibrillators, Pro-Padz Radiotransparent Electrode, SurePower
                            
                             Battery Pack, SurePower II
                            
                             Battery Pack, AED Pro® Non-Rechargeable Lithium Battery Pack, AED 3
                            
                             Battery Pack, SurePower
                            
                             Charger, and SurePower
                            
                             Single Bay Charger | 12/27/2017 |
| P170025, FDA-2018-M-0411 | Hologic, Inc | Aptima® HBV Quant Assay | 1/23/2018 |
| P160032, FDA-2018-M-0528 | Defibtech, LLC | Lifeline/ReviveR DDU-100, Lifeline/ReviveR AUTO DDU-120, Lifeline/ReviveR VIEW DDU-2300, Lifeline/ReviveR VIEW AUTO DDU-2200, Lifeline/ReviveR ECG DDU-2450, and Lifeline/ReviveR ECG+ DDU-2475 Automated External Defibrillators | 2/1/2018 |
| P140003/S018, FDA-2018-M-0620 | Abiomed, Inc | Impella Ventricular Support Systems | 2/7/2018 |
| P160037, FDA-2018-M-0736 | Becton, Dickinson and Co | BD Onclarity HPV Assay | 2/12/2018 |
| P150001/S021, FDA-2018-M-0737 | Medtronic MiniMed, Inc | MiniMed 630G System | 2/13/2018 |
| P160017/S017, FDA-2018-M-0738 | Medtronic MiniMed, Inc | MiniMed 670G System | 2/13/2018 |
| P960043/S097, FDA-2018-M-0792 | Abbott Vascular | Perclose ProGlide® Suture-Mediated Closure System | 2/16/2018 |
| P160007, FDA-2018-M-1371 | Medtronic MiniMed, Inc | Guardian Connect System | 3/8/2018 |
| H170002, FDA-2018-M-1215 | Kaneka Pharma America LLC | LIPOSORBER® LA-15 System | 3/20/2018 |
| P160013, FDA-2018-M-1237 | TransMedics, Inc | Organ Care System (OCS
                            
                            ) Lung System | 3/22/2018 |
| P050006/S060, FDA-2018-M-1372 | W.L. Gore & Associates, Inc | GORE® CARDIOFORM Septal Occluder | 3/30/2018 |
| P160018/S001, FDA-2018-M-1446 | Foundation Medicine, Inc | FoundationFocus
                            
                             CDx 
                            
                             LOH | 4/6/2018 |
| P150009, FDA-2018-M-1447 | Angel Medical Systems, Inc | AngelMed Guardian System | 4/9/2018 |
| P160052, FDA-2018-M-1581 | Parsagen Diagnostics, Inc | PartoSure Test | 4/11/2018 |
| P950039/S036, FDA-2018-M-1580 | Hologic, Inc | ThinPrep Integrated Imager | 4/18/2018 |
| P140010/S037, FDA-2018-M-1634 | Medtronic Vascular, Inc | IN.PACT
                            
                             Admiral
                            
                             Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter | 4/19/2018 |
| P960009/S219, FDA-2018-M-1727 | Medtronic, Inc | Medtronic DBS System for Epilepsy | 4/27/2018 |
| P170035, FDA-2018-M-1791 | Bausch + Lomb, Inc | Bausch + Lomb ULTRA (samfilcon A) Contact Lenses | 4/30/2018 |
| P170016, FDA-2018-M-1753 | Teva Pharmaceuticals USA, Inc | SYNOJOYNT | 5/8/2018 |
| P040024/S099, FDA-2018-M-1970 | Galderma Laboratories, LP |  | 5/18/2018 |
| P170013, FDA-2018-M-2118 | MicroVention, Inc | Low-Profile Visualized Intraluminal Support (LVIS) and LVIS Jr | 5/30/2018 |
| P170039, FDA-2018-M-2119 | Clinical Research Consultants, Inc | CustomFlex
                            
                             Artificial Iris | 5/30/2018 |
| P910056/S027, FDA-2018-M-2237 | Bausch + Lomb, Inc | enVista® One-Piece Hydrophobic Acrylic Toric Intraocular Lens (Model MX60T) | 6/8/2018 |
| P150013/S009, FDA-2018-M-2269 | Dako North America, Inc | PD-L1 IHC 22C3 pharmDx | 6/12/2018 |
| P100006/S005, FDA-2018-M-2335 | BioMimetic Therapeutics, LLC | AUGMENT® Injectable | 6/12/2018 |
| P170043, FDA-2018-M-2460 | Glaukos Corp | iStent 
                            
                             Trabecular Micro-Bypass System (Model G2-M-IS) | 6/21/2018 |
| P160017/S031, FDA-2018-M-2461 | Medtronic MiniMed, Inc | MiniMed 670G System | 6/21/2018 |
| P160048, FDA-2018-M-2463 | Senseonics, Inc | Eversense Continuous Glucose Monitoring System | 6/21/2018 |
| P180008, FDA-2018-M-2462 | Tandem Diabetes Care, Inc | t:slim X2 Insulin Pump with Basal-IQ Technology | 6/21/2018 |
| P180002, FDA-2018-M-2571 | Pulmonx Corp | Zephyr® Endobronchial Valve System | 6/29/2018 |
| P160026, FDA-2018-M-2883 | Physio-Control, Inc | LIFEPAK® 1000 Defibrillator, LIFEPAK® 1000 Defibrillator Lithium-Ion Rechargeable Battery, LIFEPAK® 1000 Defibrillator Non-Rechargeable Battery, LIFEPAK® 20 Defibrillator/Monitor (Refurbished), LIFEPAK® 20e Defibrillator/Monitor, LIFEPAK® 15 Monitor/Defibrillator, LIFEPAK® Lithium-ion Rechargeable Battery (for use with the LIFEPAK® 15 Monitor/Defibrillator) | 7/2/2018 |
| P170024, FDA-2018-M-2884 | Stryker Neurovascular | Surpass Streamline Flow Diverter | 7/13/2018 |
| P170041, FDA-2018-M-2885 | Abbott Molecular, Inc | Abbott RealTi
                            
                             IDH1 | 7/20/2018 |
| P160030/S017, FDA-2018-M-2886 | Abbott Diabetes Care Inc | FreeStyle Libre 14 Day Flash Glucose Monitoring System | 7/23/2018 |
| P160053, FDA-2018-M-2887 | Endomagnetics Ltd | Magtrace
                            
                             and Sentimag® Magnetic Localization System | 7/24/2018 |
| P170042, FDA-2018-M-2983 | C.R. Bard, Inc | COVERA
                            
                             Vascular Covered Stent | 7/30/2018 |
| P150048/S012, FDA-2018-M-3131 | Edwards Lifesciences LLC | Edwards Pericardial Mitral Bioprosthesis, Model 11000M | 8/9/2018 |
| P170034, FDA-2018-M-3153 | Ivantis, Inc | Hydrus® Microstent | 8/10/2018 |
| P150013/S011, FDA-2018-M-3212 | Dako North America, Inc | PD-L1 IHC 22C3 pharmDx | 8/16/2018 |
| P030016/S001, FDA-2018-M-3503 | STAAR Surgical Co | Visian® TORIC ICL (Implantable Collamer® Lens) | 9/13/2018 |
| H170004, FDA-2018-M-3505 | BIOTRONIK, Inc | PK Papyrus Covered Coronary Stent System | 9/14/2018 |
| P180011, FDA-2018-M-3548 | Boston Scientific Corp | ELUVIA
                            
                             Drug-Eluting Vascular Stent System | 9/18/2018 |

**II. Electronic Access**

Persons with access to the internet may obtain the documents at *https://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/PMAApprovals/default.htm* .

Dated: November 13, 2018.

Leslie Kux,

Associate Commissioner for Policy.