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 | SUTURES |
Generic Name | Suture, Nonabsorbable, Silk |
Applicant | SHARPOINT, INC. |
Date Received | 1987-05-27 |
Decision Date | 1987-08-27 |
PMA | N85143 |
Supplement | S003 |
Product Code | GAP |
Advisory Committee | General & Plastic Surgery |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Location Change - Manufacturer/sterilizer/packager/supplier |
Expedited Review | No |
Combination Product | No |
Applicant Address | SHARPOINT, INC. 824 Twelfth Ave. bethlehem, PA 18018 |
Supplement Number | Date | Supplement Type |
---|---|---|
N85143 | Original Filing | |
S007 | 1988-06-21 | Normal 180 Day Track |
S006 | 1988-02-16 | Normal 180 Day Track |
S005 | 1987-09-10 | Normal 180 Day Track |
S004 | 1987-06-03 | Normal 180 Day Track |
S003 | 1987-05-27 | Normal 180 Day Track |
S002 | 1987-02-13 | Normal 180 Day Track |
S001 | 1984-12-26 |
Device ID | PMA | Supp |
---|---|---|
10848782013026 | N85143 | 007 |