Medical Devices

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

TYPE OF SUBMISSION	2000 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 PMAs	42	53	41	31	29	28	27	27	16	17
PMA Supplements	474	442	533	494	424	354	594	578	630	715
Original IDEs	320	284	307	246	217	238	234	214	215	221
IDE Amendments	251	207	251	217	162	208	178	163	184	199
IDE Supplements	4,335	4,802	4,711	4,424	4,336	4,226	4,430	4,324	4,369	4,268
510(k)s	4,397	4,150	4,376	4,132	3,376	3,184	3,080	3,052	3,238	3,361
Original HDE	6	4	10	2	6	2	3	2	2	4
HDE Supplements	10	11	14	24	22	31	69	47	42	40
Total	9,835	9,953	10,243	9,570	8,573	8,272	8,615	8,407	8,696	8,825