|
Device | GELFOAM (ABSORBABLE GELATIN) PLUS HEMOSTATIS KIT |
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 | S019 |
Date Received | 03/17/2010 |
Decision Date | 04/08/2010 |
Product Code |
LMF |
Advisory Committee |
General & Plastic Surgery |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL TO ADD A STATEMENT IN THE CONTRAINDICATIONS SECTION OF THE LABELING TO ADDRESS THE POTENTIAL RISK IN PATIENTS WITH KNOWN ALLERGIES TO PORCINE COLLAGEN. |