PMA N18286S024

Device: GELFOAM (ABSORABLE GELATIN) POWDER, USP
Applicant: Pfizer, Inc.
PMA number: N18286
Supplement: S024
Product code: LMF
Decision date: 2013-01-07
Classification: Agent, Absorbable Hemostatic, Collagen Based
Generic name: Agent, absorbable hemostatic, collagen based
Approval order statement: APPROVAL FOR A MINOR CHANGE IN LABELING INSTRUCTIONS TO INCLUDE MIXING GELFOAM POWDER WITH DILUENTS OF SALINE FOR INJECTION OR THROMBIN. NO OTHER CHANGE INCLUDED IN THIS APPROVAL ORDER. THE DEVICE ALONG WITH THE MODIFIED LABELING WILL BE MARKETED UNDER THE TRADE NAME GELFOAM ABSORBABLE GELATIN POWDER: IS INTENDED AS A HEMOSTATIC DEVICE FOR SURGICAL PROCEDURES WHEN CONTROL OF CAPILLARY, VENOUS AND ARTERIOLAR BLEEDING BY PRESSURE, LIGATURE, AND OTHER CONVENTIONAL PROCEDURES IS EITHER INEFFECTIVE OR IMPRACTICAL. ALTHOUGH NOT NECESSARY, GELFOAM STERILE POWDER CAN BE USED EITHER WITH OR WITHOUT THROMBIN TO OBTAIN HEMOSTASIS.

Current openFDA PMA Record#

Device: GELFOAM (ABSORABLE GELATIN) POWDER, USP
Applicant: Pfizer, Inc.
PMA number: N18286
Supplement: S024
Product code: LMF
Generic name: Agent, absorbable hemostatic, collagen based
Decision date: 2013-01-07
Decision code: APPR
Date received: 2012-11-26
Supplement type: Real-Time Process
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: APPROVAL FOR A MINOR CHANGE IN LABELING INSTRUCTIONS TO INCLUDE MIXING GELFOAM POWDER WITH DILUENTS OF SALINE FOR INJECTION OR THROMBIN. NO OTHER CHANGE INCLUDED IN THIS APPROVAL ORDER. THE DEVICE ALONG WITH THE MODIFIED LABELING WILL BE MARKETED UNDER THE TRADE NAME GELFOAM ABSORBABLE GELATIN POWDER: IS INTENDED AS A HEMOSTATIC DEVICE FOR SURGICAL PROCEDURES WHEN CONTROL OF CAPILLARY, VENOUS AND ARTERIOLAR BLEEDING BY PRESSURE, LIGATURE, AND OTHER CONVENTIONAL PROCEDURES IS EITHER INEFFECTIVE OR IMPRACTICAL. ALTHOUGH NOT NECESSARY, GELFOAM STERILE POWDER CAN BE USED EITHER WITH OR WITHOUT THROMBIN TO OBTAIN HEMOSTASIS.