PMA N18286S019

Device: GELFOAM (ABSORBABLE GELATIN) PLUS HEMOSTATIS KIT
Applicant: Pfizer, Inc.
PMA number: N18286
Supplement: S019
Product code: LMF
Decision date: 2010-04-08
Classification: Agent, Absorbable Hemostatic, Collagen Based
Generic name: Agent, absorbable hemostatic, collagen based
Approval order statement: APPROVAL TO ADD A STATEMENT IN THE CONTRAINDICATIONS SECTION OF THE LABELING TO ADDRESS THE POTENTIAL RISK IN PATIENTS WITH KNOWN ALLERGIES TO PORCINE COLLAGEN.

Current openFDA PMA Record#

Device: GELFOAM (ABSORBABLE GELATIN) PLUS HEMOSTATIS KIT
Applicant: Pfizer, Inc.
PMA number: N18286
Supplement: S019
Product code: LMF
Generic name: Agent, absorbable hemostatic, collagen based
Decision date: 2010-04-08
Decision code: APPR
Date received: 2010-03-17
Supplement type: Special (Immediate Track)
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: APPROVAL TO ADD A STATEMENT IN THE CONTRAINDICATIONS SECTION OF THE LABELING TO ADDRESS THE POTENTIAL RISK IN PATIENTS WITH KNOWN ALLERGIES TO PORCINE COLLAGEN.