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 SURGICAL SUTURES |
| Generic Name | Suture, Nonabsorbable, Silk |
| Applicant | SHARPOINT, INC. |
| Date Received | 1988-02-16 |
| Decision Date | 1988-03-22 |
| PMA | N85143 |
| Supplement | S006 |
| 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 |