|
Device | (Gelfoam (absorbable gelatin) Sterile Sponge) |
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 | S040 |
Date Received | 05/27/2022 |
Decision Date | 06/24/2022 |
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 for updating the Gelfoam Instructions for Use to include language on visualization of the target bleeding site before application and to update the Adverse Reactions section to include duct stenosis (such as bile duct stenosis). |