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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2010-M-0068, FDA-2010-M-0078, FDA-2010-M-0063, FDA-2010-M-0135, FDA-2010-M-0158]

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 of this document 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 the

Federal Register

of January 30, 1998 (63 FR 4571), FDA published a final rule that revised 21 CFR 814.44(d) and 814.45(d) to discontinue individual publication of PMA approvals and denials in the

Federal Register

. Instead, the agency now posts this information on the Internet on FDA's home page at

http://www.fda.gov

. FDA believes that this procedure expedites public notification of these actions because announcements can be placed on the Internet more quickly than they can be published in the

Federal Register

, and FDA believes that the Internet is accessible to more people than the

Federal Register

.

In accordance with section 515(d)(4) and (e)(2) of the Federal Food, Drug, and Cosmetic Act (the 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 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 January 1, 2010, through March 31, 2010. 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.

Table 1—List of Safety and Effectiveness Summaries for Approved PMAs Made Available From January 1, 2010, through March 31, 2010

PMA No.

Docket No.

Applicant

Trade Name

Approval Date

P010047

FDA-2010-M-0068

Neomend, Inc.

PROGEL PLEURAL AIR LEAK SEALANT

January 14, 2010

P060040/S005

FDA-2010-M-0078

Thoratec Corp.

THORATEC HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM (LVAS)

January 20, 2010

H080002

FDA-2010-M-0063

Medtronic, Inc.

MEDTRONIC MELODY TRANSCATHETER PULMONARY VALVE (MODEL PB10) AND MEDTRONIC ENSEMBLE TRANSCATHETER VALVE DELIVERY SYSTEM (NU10)

January 25, 2010

P090003

FDA-2010-M-0135

Boston Scientific Corp.

EXPRESS LD LLIAC PREMOUNTED STENT SYSTEM

March 5, 2010

P090006

FDA-2010-M-0158

Medtronic Vascular

COMPLETE SE VASCULAR STENT SYSTEM

March 17, 2010

II. Electronic Access

Persons with access to the Internet may obtain the documents at

http://www.fda.gov/cdrh/pmapage.html

.

Dated: June 28, 2010.

Nancy Stade,

Acting Associate Director for Regulations and Policy, Center for Devices and Radiological Health.

[FR Doc. 2010-16139 Filed 7-1-10; 8:45 am]

BILLING CODE 4160-01-S