P880001S

None

FDA Premarket Approval P880001 S

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: P880001S
• Classification Name: None
• PMA: P880001
• Supplement: S

Supplemental Filings

Supplement Number	Date	Supplement Type
P880001		Original Filing
S040	1993-10-29	Normal 180 Day Track
S039	1993-08-24	Normal 180 Day Track
S038	1993-04-19	Normal 180 Day Track
S037	1993-02-05	Normal 180 Day Track
S036	1992-08-19	Normal 180 Day Track
S035	1992-06-01	Normal 180 Day Track
S034	1992-04-03	Normal 180 Day Track
S033	1992-03-12	Normal 180 Day Track
S032	1992-01-10	Normal 180 Day Track
S031	1991-11-25	Normal 180 Day Track
S030	1991-07-29	Normal 180 Day Track
S029	1990-10-22	Normal 180 Day Track
S028	1990-09-06	Normal 180 Day Track
S027	1990-07-23	30-Day Supplement
S026	1990-05-31	30-Day Supplement
S025	1990-03-15	Normal 180 Day Track
S024	1989-11-13	Normal 180 Day Track
S023	1989-10-12	Normal 180 Day Track
S022
S021	1989-09-05	Normal 180 Day Track
S020	1989-08-08	Normal 180 Day Track
S019	1989-07-21	Normal 180 Day Track
S018	1989-07-19	Normal 180 Day Track
S017	1989-06-23	Normal 180 Day Track
S016	1989-06-19	Normal 180 Day Track
S015	1989-05-22	Normal 180 Day Track
S014	1989-05-17	Normal 180 Day Track
S013	1989-04-19	Normal 180 Day Track
S012	1989-03-24	Normal 180 Day Track
S011	1989-03-01	Normal 180 Day Track
S010	1989-02-16	Normal 180 Day Track
S009	1989-02-14	Normal 180 Day Track
S008	1989-02-08	Normal 180 Day Track
S007	1989-01-13	Normal 180 Day Track
S006	1988-12-19	Normal 180 Day Track
S005	1988-11-23	Normal 180 Day Track
S004	1988-11-21	30-Day Supplement
S003	1988-10-18	Normal 180 Day Track
S002	1988-10-07	Normal 180 Day Track
S001	1988-10-03	30-Day Supplement

NIH GUDID Devices

Device ID	PMA	Supp
B316FLX7000	P880001	028
B316FLX500UV0	P880001	028
B316FLX3000	P880001	028