Document headings vary by document type but may contain
                    the following: the agency or agencies that issued and signed a document
the number of the CFR title and the number of each part
                      the document amends, proposes to amend, or is directly
                      related to
the agency docket number / agency internal file number
the RIN which identifies each regulatory action listed in
                      the Unified Agenda of Federal Regulatory and Deregulatory
                      Actions See the
                    Document Drafting Handbook
                    for more details.
 Department of Health and Human Services Food and Drug Administration [Docket Nos. FDA-2008-M-0084, FDA-2008-M-0100 (formerly 2008M-0013), FDA-2008-M-0182, FDA-2008-M-0109, FDA-2008-M-0207]
 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: Samie Allen, Center for Devices and Radiological Health (HFZ-402), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 240-276-4013.


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, 2008, through March 31, 2008. 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, 2008, through March 31, 2008**
PMA No.
                             Docket No.
Applicant
TRADE NAME
Approval DateP040021 (S004)
                             FDA-2008-M-0084
St. Jude Medical, Inc.
SJM EPIC VALVE AND SJM SUPRA VALVE
November 15, 2007( print page 50827)P070001
                             FDA-2008-M-0100 (formerly 2008M-0013)
Synthes Spine, Inc.
PRODISC-C TOTAL DISC PEPLACEMENT
December 17, 2007P050045
                             FDA-2008-M-0182
Dako Denmark a/s
DAKO TOP2A FISH PHARM DX KIT
January 11, 2008P060033
                             FDA-2008-M-0109
Medtronic Vascular
ENDEAVOR ZOTAROLIMUS-ELUTING CORONARY STENT ON THE OVER THE WIRE (OTW), RAPID EXCHANGE (RX), OR MULTI-EXHANGE II (MX2
                            ) STENT DELIVERY SYSTEM
February 1, 2008
 II. Electronic Access Persons with access to the Internet may obtain the documents at 
                    *http://www.fda.gov/​cdrh/​pmapage.html*. Dated: August 14, 2008. Daniel G. Schultz, Director, Center for Devices and Radiological Health.


[FR Doc. E8-19907 Filed 8-27-08; 8:45 am] BILLING CODE 4160-01-S