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 | MAXON(TM) POLYGLYCONATE MONOFILAMENT ABSORBABLE SU |
Generic Name | Suture, Absorbable, Synthetic, Polyglycolic Acid |
Applicant | DAVIS & GECK, INC. |
Date Received | 1991-02-20 |
Decision Date | 1991-03-29 |
PMA | P840051 |
Supplement | S004 |
Product Code | GAM |
Advisory Committee | General & Plastic Surgery |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
Expedited Review | No |
Combination Product | No |
Applicant Address | DAVIS & GECK, INC. 1 Casper St. danbury, CT 06810 |
Supplement Number | Date | Supplement Type |
---|---|---|
P840051 | Original Filing | |
S008 | 1996-10-30 | Real-time Process |
S007 | 1995-12-19 | Special (immediate Track) |
S006 | 1991-10-02 | Normal 180 Day Track |
S005 | 1991-08-07 | Normal 180 Day Track |
S004 | 1991-02-20 | Normal 180 Day Track |
S003 | 1989-05-15 | Normal 180 Day Track |
S002 | ||
S001 | 1987-04-14 | Normal 180 Day Track |