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U.S. Department of Health and Human Services

Medical Devices

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Major Submissions Completed FY00 - FY09 (MDUFMA FDA Performance Report October 27, 2010)

TYPE OF SUBMISSION2000
ODE& OIVD
2001
ODE& OIVD
2002
ODE& OIVD
2003
ODE& OIVD
2004
ODE Only
2005
ODE Only
2006
ODE Only
2007
ODE Only
2008
ODE Only
2009
ODE Only
Original PMAs42534131292827271617
PMA Supplements474442533494424354594578630715
Original IDEs320284307246217238234214215221
IDE Amendments251207251217162208178163184199
IDE Supplements4,3354,8024,7114,4244,3364,2264,4304,3244,3694,268
510(k)s4,3974,1504,3764,1323,3763,1843,0803,0523,2383,361
Original HDE64102623224
HDE Supplements10111424223169474240
Total 9,835 9,953 10,243 9,570 8,5738,2728,615 8,407 8,6968,825