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Device | GELFOAM ABLSORBABLE GELATIN SPONGE AND GELFILM STERILE FILM |
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 | S013 |
Date Received | 02/19/2002 |
Decision Date | 03/20/2002 |
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 CHANGE TO THE BACTERIAL ENDOTOXIN TEST METHOD FOR GELFOAM ABSORBABLE GELATIN SPONGE AND GELFILM STERILE FILM IN ORDER TO COMPLY WITH THE RECENTLY HARMONIZED USP, EP AND JP COMPENDIA FOR BACTERIAL ENDOTOXIN ASSAY. |