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P880001 510(k) FDA Approval

P880001

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

DeviceP880001
Classification NameNone
Applicant
PMAP880001
SupplementS

Supplemental Filings

Supplement NumberDateSupplement Type
P880001Original 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 IDPMASupp
B316FLX7000 P880001 028
B316FLX500UV0 P880001 028
B316FLX3000 P880001 028

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