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 | CHROMIC GUT SUTURE |
Generic Name | Suture, Absorbable, Natural |
Applicant | DEKNATEL, INC. |
Date Received | 1984-05-09 |
Decision Date | 1984-07-12 |
PMA | N84381 |
Supplement | S004 |
Product Code | GAL |
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 |
---|---|---|
N84381 | Original Filing | |
S008 | 1988-03-31 | Normal 180 Day Track |
S007 | 1987-12-30 | Normal 180 Day Track |
S006 | 1987-09-18 | Normal 180 Day Track |
S005 | 1984-06-21 | |
S004 | 1984-05-09 | |
S003 | 1983-04-14 | |
S002 | 1981-04-08 | |
S001 | 1981-02-05 |