This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.
Device | HALLMARK ABSORBO ABSORBABLE DUSTING POWDER |
Generic Name | Powder, Dusting, Surgical |
Applicant | INGREDION INCORPORATED |
Date Received | 1989-08-21 |
Decision Date | 1989-12-13 |
PMA | N80535 |
Supplement | S005 |
Advisory Committee | General Hospital |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Location Change - Manufacturer/sterilizer/packager/supplier |
Expedited Review | No |
Combination Product | No |
Applicant Address | INGREDION INCORPORATED 10 Finderne Avenue suite C bridgewater, NJ 08807 |
Supplement Number | Date | Supplement Type |
---|---|---|
N80535 | Original Filing | |
S009 | 1999-03-19 | Normal 180 Day Track |
S008 | ||
S007 | ||
S006 | 1990-05-22 | Normal 180 Day Track |
S005 | 1989-08-21 | Normal 180 Day Track |
S004 | 1974-09-08 | Normal 180 Day Track |
S003 | 1973-03-02 | Normal 180 Day Track |
S002 | 1973-03-02 | Normal 180 Day Track |
S001 | 1973-03-02 | Normal 180 Day Track |