FDA.reportPublic FDA data

PMA N18286S034

Device
Gelfoam (absorbable gelatin) Sterile Sponge
Applicant
Pfizer, Inc.
PMA number
N18286
Supplement
S034
Product code
LMF
Decision date
2020-02-27
Generic name
Agent, absorbable hemostatic, collagen based
Approval order statement
Implementation of the alternate bulk sterilization procedure for GEL-FLOW NT that is further processed into GEL-FLOW Kits and the addition of the protective laminate coating and update to the ribbon stock for the GEL-FLOW NT outer pouch label.

Current openFDA PMA Record#

Device
Gelfoam (absorbable gelatin) Sterile Sponge
Applicant
Pfizer, Inc.
PMA number
N18286
Supplement
S034
Product code
LMF
Generic name
Agent, absorbable hemostatic, collagen based
Decision date
2020-02-27
Decision code
OK30
Date received
2020-01-29
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Implementation of the alternate bulk sterilization procedure for GEL-FLOW NT that is further processed into GEL-FLOW Kits and the addition of the protective laminate coating and update to the ribbon stock for the GEL-FLOW NT outer pouch label.