|
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 | S034 |
Date Received | 01/29/2020 |
Decision Date | 02/27/2020 |
Product Code |
LMF |
Advisory Committee |
General & Plastic Surgery |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Implementation of the alternate bulk sterilization procedure for GEL-FLOW NT that is further processed into GEL-FLOW Kits and the addition of the protective laminate coating and update to the ribbon stock for the GEL-FLOW NT outer pouch label. |