LEADER 01618nam  2200361Ia 450 
001 9910698835203321
005 20090522155326.0
035   $a(CKB)5470000002397515
035   $a(OCoLC)341768072
035   $a(EXLCZ)995470000002397515
100   $a20090522d2003      ua             0
101 0 $aeng
135   $auran|||||||||
181   $ctxt$2rdacontent
182   $cc$2rdamedia
183   $acr$2rdacarrier
200 00$aPremarket approval application modular review$b[electronic resource]
210  1$aRockville, MD :$cU.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Devices and Radiological Health :$cCenter for Biologics Evaluation and Research,$d[2003]
215   $a14 pages $cdigital, PDF file
300   $aTitle from PDF title page (viewed on May 22, 2009).
300   $a"Document issued on: November 3, 2003".
300   $a"Supersedes and replaces " A modular approach to PMA review ", dated January 29, 1998, and "Guidance for the medical device industry on PMA shell development and modular review", dated November 6, 1998".
517 1 $aGuidance for industry and FDA staff
606   $aMedical instruments and apparatus$xEvaluation$xGovernment policy$zUnited States
615  0$aMedical instruments and apparatus$xEvaluation$xGovernment policy
712 02$aCenter for Devices and Radiological Health (U.S.)
712 02$aCenter for Biologics Evaluation and Research (U.S.)
801  0$bGPO
801  1$bGPO
906   $aBOOK
912   $a9910698835203321
996   $aPremarket approval application modular review$93174876
997   $aUNINA