Health and Human Services Department, Food and Drug Administration
The Food and Drug Administration (FDA) is publishing a list of premarket approval applications (PMA's) that have been approved. This list is intended to inform the public of the availability of safety and effectiveness summaries of approved PMA's through the Internet and the agency's Dockets Management Branch.
Document Headings 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. 00M-1391, 00M-1536, 00M-1447, 00M-1522, 00M-0809, 00M-1517, 00M-1451, 00M-1448, 00M-1507, 00M-1389, 00M-1388, 00M-1508, 00M-1390, 00M-1386, 00M-1387, 00M-1414, 00M-1415, 00M-1416, 00M-1495, 00M-1437, 00M-1475, 00M-1483, 00M-1515, 00M-1524, 00M-1523] AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is publishing a list of premarket approval applications (PMA's) that have been approved. This list is intended to inform the public of the availability of safety and effectiveness summaries of approved PMA's through the Internet and the agency's Dockets Management Branch. ADDRESSES: Submit a written request for copies of summaries of safety and effectiveness to the Dockets Management Branch (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 summary of safety and effectiveness FOR FURTHER INFORMATION CONTACT: Thinh Nguyen, Center for Devices and Radiological Health (HFZ-402), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-594-2186. SUPPLEMENTARY INFORMATION: I. Background In the Federal Register of January 30, 1998 ( 63 FR 4571 ), FDA published a final rule to revise §§ 814.44(d…
Citation: 65 FR 78495
