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

---
identifier: "/us/fr/2013-20085"
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: "2013-20085"
section_name: "Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications"
positive_law: false
currency: "2013-08-19"
last_updated: "2013-08-19"
format_version: "1.1.0"
generator: "[email protected]"
agency: "Health and Human Services Department"
document_number: "2013-20085"
document_type: "notice"
publication_date: "2013-08-19"
agencies:
  - "Health and Human Services Department"
  - "Food and Drug Administration"
fr_citation: "78 FR 50422"
fr_volume: 78
docket_ids:
  - "Docket Nos. FDA-2013-M-0462, FDA-2013-M-0463, FDA-2013-M-0464, FDA-2013-M-0549, FDA-2013-M-0592, FDA-2013-M-0594, FDA-2013-M-0595, FDA-2013-M-0709, FDA-2013-M-0724, FDA-2013-M-0738, and FDA-2013-M-0758"
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) 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 Division of Dockets Management.

**ADDRESSES:**

Submit written requests for copies of summaries of safety and effectiveness data to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Please cite the appropriate docket number as listed in table 1 when submitting a written request. See the *SUPPLEMENTARY INFORMATION* section for electronic access to the summaries of safety and effectiveness.

**FOR FURTHER INFORMATION CONTACT:**

Nicole Wolanski, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 1650, Silver Spring, MD 20993-0002, 301-796-6570.

**SUPPLEMENTARY INFORMATION:**

**I. Background**

In accordance with sections 515(d)(4) and (e)(2) of the Federal Food, Drug, and Cosmetic Act (the 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 quarterly 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 April 1, 2013, through June 30, 2013. 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 |
| --- | --- | --- | --- |
| P120016, FDA-2013-M-0592 | Cardiva Medical, Inc. | VASCADE Vascular Closure System (VCS) | January 31, 2013. |
| P070026/S004, FDA-2013-M-0462 | DePuy Orthopaedics, Inc. | DuPuy Ceramax Ceramic Total Hip System | April 2, 2013. |
| P960043/S080, FDA-2013-M-0464 | Abbott Vascular | PERCLOSE PROGLIDE Suture Mediated Closure System | April 15, 2013. |
| P980040/S039, FDA-2013-M-0463 | Abbott Medical Optics, Inc. | TECNIS Toric 1-Piece Intraocular Lens (IOL) and the TECNIS Toric Calculator System | April 15, 2013. |
| P080009, FDA-2013-M-0549 | Ethicon Endo-Surgery, Inc. | SEDASYS Computer-Assisted Personalized Sedation System | May 3, 2013. |
| P120019, FDA-2013-M-0594 | Roche Molecular Systems, Inc. | COBAS EGFR Mutation Test | May 14, 2013. |
| P080003/S001, FDA-2013-M-0595 | Hologic, Inc. | Selenia Dimensions 3D System | May 16, 2013. |
| P030002/S027, FDA-2013-M-0724 | Bausch+Lomb, Inc. | TRULIGN Toric Posterior Chamber Intraocular Lens | May 20, 2013. |
| P120014, FDA-2013-M-0709 | bioMérieux, Inc. | THxID BRAF Kit for use on the ABI 7500 Fast DX Real-Time PCR Instrument | May 29, 2013. |
| P060028, FDA-2013-M-0738 | Mentor Worldwide LLC | MEMORYSHAPE Breast Implants | June 14, 2013. |
| P120012, FDA-2013-M-0758 | Abbott Molecular, Inc. | Abbott RealTi
                            
                            e HCV Genotype II, Abbott RealTi
                            
                            e HCV Genotype II Control Kit, and Uracil-N-Glycosylase (UNG) | June 20, 2013. |

**II. Electronic Access**

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

Dated: August 13, 2013.

Leslie Kux,

Assistant Commissioner for Policy.