Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications
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.
Table of Contents Back to Top
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ADDRESSES: Back to Top
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: Back to Top
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: Back to Top
I. Background Back to Top
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.
|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 Back to Top
Persons with access to the Internet may obtain the documents at http://www.fda.gov/cdrh/pmapage.html.
Dated: June 28, 2010.
Acting Associate Director for Regulations and Policy, Center for Devices and Radiological Health.
[FR Doc. 2010-16139 Filed 7-1-10; 8:45 am]
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