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 | NONABSORBABLE SURG. SUTURES, NYLON |
Classification Name | Suture, Nonabsorbable, Synthetic, Polyamide |
Generic Name | Suture, Nonabsorbable, Synthetic, Polyamide |
Applicant | DEKNATEL, INC. |
Date Received | 1984-06-21 |
Decision Date | 1985-02-27 |
PMA | N85060 |
Supplement | S002 |
Product Code | GAR |
Advisory Committee | General & Plastic Surgery |
Expedited Review | No |
Combination Product | No |
Applicant Address | DEKNATEL, INC. 600 Airport Rd. fall River, MA 02720 |
Supplement Number | Date | Supplement Type |
---|---|---|
N85060 | Original Filing | |
S007 | 1989-05-09 | Normal 180 Day Track |
S006 | 1988-03-31 | Normal 180 Day Track |
S005 | 1987-12-30 | Normal 180 Day Track |
S004 | 1987-09-18 | Normal 180 Day Track |
S003 | 1987-06-09 | Normal 180 Day Track |
S002 | 1984-06-21 | |
S001 | 1980-09-23 |