FDA.reportPublic FDA data

PMA N18286S040

Device
(Gelfoam (absorbable gelatin) Sterile Sponge)
Applicant
Pfizer, Inc.
PMA number
N18286
Supplement
S040
Product code
LMF
Decision date
2022-06-24
Generic name
Agent, absorbable hemostatic, collagen based
Approval order statement
Approval for updating the Gelfoam Instructions for Use to include language on visualization of the target bleeding site before application and to update the Adverse Reactions section to include duct stenosis (such as bile duct stenosis).

Current openFDA PMA Record#

Device
(Gelfoam (absorbable gelatin) Sterile Sponge)
Applicant
Pfizer, Inc.
PMA number
N18286
Supplement
S040
Product code
LMF
Generic name
Agent, absorbable hemostatic, collagen based
Decision date
2022-06-24
Decision code
APPR
Date received
2022-05-27
Supplement type
Special (Immediate Track)
Supplement reason
Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement
Approval for updating the Gelfoam Instructions for Use to include language on visualization of the target bleeding site before application and to update the Adverse Reactions section to include duct stenosis (such as bile duct stenosis).