PMA N18286S013

Device: GELFOAM ABLSORBABLE GELATIN SPONGE AND GELFILM STERILE FILM
Applicant: Pfizer, Inc.
PMA number: N18286
Supplement: S013
Product code: LMF
Decision date: 2002-03-20
Classification: Agent, Absorbable Hemostatic, Collagen Based
Generic name: Agent, absorbable hemostatic, collagen based
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.

Current openFDA PMA Record#

Device: GELFOAM ABLSORBABLE GELATIN SPONGE AND GELFILM STERILE FILM
Applicant: Pfizer, Inc.
PMA number: N18286
Supplement: S013
Product code: LMF
Generic name: Agent, absorbable hemostatic, collagen based
Decision date: 2002-03-20
Decision code: OK30
Date received: 2002-02-19
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
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.