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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	39	44	66	48	64	67	71	49	54	37	43
PMA Supplements	499	415	409	517	557	546	641	645	666	565	712
Original IDEs	214	253	297	322	304	311	284	312	242	222	226
IDE Supplements	3,171	3,189	3,776	4,277	4,127	4,388	4,811	4,724	4,415	4,298	4,262
510(k)s	6,056	5,297	5,049	4,623	4,458	4,202	4,248	4,320	4,247	3,107	3,130
Original HDE	0	0	4	8	12	11	5	5	10	9	4
HDE Supplements	0	0	0	0	4	10	16	16	29	28	24
513(g)s	2	29	34	43	59	82	104	156	270	313
Total	9,979	9,200	9,630	9,829	9,569	9,594	10,158	10,194	9,819	8,536	8,714
a Office of Device Evaluation and Division of Clinical Laboratory Devices or Office of In Vitro Diagnostics. b Office of Device Evaluation only.

Table I. Major submissions received, FY95–FY05. Source: FDA Office of Device Evaluation.