|
Device | GELFOAM ABSORBABLE GELATIN POWDER |
Generic Name | Agent, absorbable hemostatic, collagen based |
Regulation Number | 878.4490 |
Applicant | PFIZER, INC. 235 EAST 42ND ST. NEW YORK, NY 10017 |
PMA Number | N18286 |
Supplement Number | S011 |
Date Received | 04/05/1999 |
Decision Date | 04/26/1999 |
Product Code |
LMF |
Advisory Committee |
General & Plastic Surgery |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for changing the name of the product form Gelfoam Sterile Powder to Gelfoam Absorbable Gelatin Powder. |