PMA N18286S020

Device: GELFOAM ABSORBABLE GELATIN SPONGE
Applicant: Pfizer, Inc.
PMA number: N18286
Supplement: S020
Product code: LMF
Decision date: 2010-10-19
Classification: Agent, Absorbable Hemostatic, Collagen Based
Generic name: Agent, absorbable hemostatic, collagen based
Approval order statement: APPROVAL FOR AN UPDATE TO THE LABELING TO INCLUDE THE CONTRAINDICATION: ¿DO NOT USE GELFOAM ABSORBABLE GELATIN SPONGE IN PATIENTS WITH KNOWN ALLERGIES TO PORCINE COLLAGEN.¿

Current openFDA PMA Record#

Device: GELFOAM ABSORBABLE GELATIN SPONGE
Applicant: Pfizer, Inc.
PMA number: N18286
Supplement: S020
Product code: LMF
Generic name: Agent, absorbable hemostatic, collagen based
Decision date: 2010-10-19
Decision code: APPR
Date received: 2010-10-12
Supplement type: Special (Immediate Track)
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: APPROVAL FOR AN UPDATE TO THE LABELING TO INCLUDE THE CONTRAINDICATION: ¿DO NOT USE GELFOAM ABSORBABLE GELATIN SPONGE IN PATIENTS WITH KNOWN ALLERGIES TO PORCINE COLLAGEN.¿