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 | SILK SUTURES |
Classification Name | Suture, Nonabsorbable, Silk |
Generic Name | Suture, Nonabsorbable, Silk |
Applicant | LUKENS CORP. |
Date Received | 1988-02-24 |
Decision Date | 1988-03-16 |
PMA | N80989 |
Supplement | S003 |
Product Code | GAP |
Advisory Committee | General & Plastic Surgery |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
Expedited Review | No |
Combination Product | No |
Applicant Address | LUKENS CORP. 51 Chubb Way somerville, NJ 08876 |
Supplement Number | Date | Supplement Type |
---|---|---|
N80989 | Original Filing | |
S005 | 1988-07-20 | Normal 180 Day Track |
S004 | 1988-05-24 | Normal 180 Day Track |
S003 | 1988-02-24 | Normal 180 Day Track |
S002 | ||
S001 | 1987-03-06 | Normal 180 Day Track |