Untitled Document

Type of Submission	1995^a	1996^a	1997^a	1998^a	1999^a	2000^a	2001^a	2002^a	2003^a	2004^b	2005^b
Original PMAs	27	43	48	40	36	42	53	41	31	30	29
PMA Supplements	435	462	401	421	440	474	442	533	494	424	354
Original IDEs	210	260	272	325	305	320	284	307	246	217	238
IDE Amendments	213	218	220	225	268	251	207	251	217	162	208
IDE Supplements	3,181	3,121	3,777	4,209	4,224	4,335	4,803	4,711	4,424	4,336	4,226
510(k)s	7,948	5,563	5,155	5,229	4,593	4,397	4,150	4,376	4,132	3,376	3,184
Original HDE	0	0	2	4	6	6	4	6	2	6	2
HDE Supplements	0	0	0	0	3	10	11	13	24	22	31
Total	12,014	9,667	9,875	10,453	9,876	9,835	9,954	10,238	9,570	8,573	8,272
a Office of Device Evaluation and Division of Clinical Laboratory Devices or Office of In Vitro Diagnostics. b Office of Device Evaluation only.

Table II. Major submissions completed, FY95–FY05. Source: FDA Office of Device Evaluation.