P970018S008

None

FDA Premarket Approval P970018 S008

This post-approval study has not been publically released by the fda. It may be a place-holder supplement number.

Pre-market Approval Supplement Details

• Device: P970018S008
• Classification Name: None
• PMA: P970018
• Supplement: S008

Supplemental Filings

Supplement Number	Date	Supplement Type
P970018		Original Filing
S039	2021-09-24	Real-time Process
S038	2021-02-19	Real-time Process
S037	2021-01-21	30-day Notice
S036	2017-10-10	Normal 180 Day Track No User Fee
S035	2017-07-17	Normal 180 Day Track No User Fee
S034	2016-05-31	30-day Notice
S033	2016-05-27	Real-time Process
S032	2015-03-26	Normal 180 Day Track
S031	2015-01-22	Normal 180 Day Track No User Fee
S030	2014-11-03	Normal 180 Day Track
S029	2013-11-15	30-day Notice
S028	2013-10-31	Normal 180 Day Track
S027	2013-09-30	Special (immediate Track)
S026
S025	2012-05-18	135 Review Track For 30-day Notice
S024	2011-08-24	Special (immediate Track)
S023	2011-06-27	Special (immediate Track)
S022
S021	2010-04-05	Real-time Process
S020	2010-02-18	30-day Notice
S019	2009-10-22	Normal 180 Day Track
S018	2009-09-08	Normal 180 Day Track No User Fee
S017	2009-06-11	Normal 180 Day Track
S016	2009-06-09	30-day Notice
S015	2009-05-27	Real-time Process
S014	2008-07-21	Real-time Process
S013
S012	2007-04-19	Special (immediate Track)
S011
S010	2005-09-01	Real-time Process
S009	2005-01-10	Real-time Process
S008
S007	2003-12-01	Normal 180 Day Track
S006	2003-03-24	Normal 180 Day Track
S005	2002-08-26	Normal 180 Day Track
S004	2002-07-02	Normal 180 Day Track
S003	2001-10-26	Real-time Process
S002	2000-12-01	Normal 180 Day Track
S001	2000-08-08	Real-time Process

NIH GUDID Devices

Device ID	PMA	Supp
30382904905201	P970018	000
00382904901004	P970018	000
00382904913113	P970018	000
00382904912895	P970018	000
00382904913328	P970018	000
00382904913373	P970018	000
30382904913305	P970018	000
30382904913299	P970018	000
30382904913244	P970018	000
00382904912673	P970018	000
00382904912666	P970018	000
00382904914547	P970018	000
00382904913069	P970018	000
00382904904074	P970018	001
00382904905231	P970018	001
00382904912475	P970018	001
00382904905286	P970018	001
00382904905408	P970018	001
00382904905217	P970018	001
30382904905225	P970018	001
00382904909857	P970018	001
30382904905119	P970018	001
00382904905415	P970018	001
00382904905071	P970018	001
00382904910952	P970018	002
00382904904104	P970018	002
00382904901042	P970018	002
30382904905171	P970018	002
10382904905276	P970018	002
10382904913318	P970018	002
30382904913312	P970018	002
00382904914554	P970018	002
00382904913137	P970018	002
00382904910969	P970018	002
00382904910976	P970018	002
30382904912483	P970018	025
00382904911034	P970018	028
00382904912574	P970018	028
00382904912888	P970018	028
00382904914561	P970018	030
00382904913885	P970018	030
00382904913465	P970018	030
00382904913083	P970018	030
30382904914524	P970018	032
10382904912533	P970018	032
00382904914530	P970018	032
00382904914400	P970018	032
00382904913106	P970018	032
00382904914394	P970018	032
00382904433277	P970018	032
00382904914387	P970018	032
00382904913892	P970018	032