PMA N18286

Device: GELFOAM (absorbable gelatin gel, powder from abs. gel, sponge USP), GELFOAM (compressed absorbable gelatin sponge, USP),
Applicant: Pfizer, Inc.
PMA number: N18286
Supplement: S040
Product code: LMF
Decision date: 2023-05-16
Generic name: Agent, absorbable hemostatic, collagen based
Approval order statement: Change of a new nitrogen flowmeter and a change in the in-process brick dimensions.

Current openFDA PMA Record#

Device: GELFOAM (absorbable gelatin gel, powder from abs. gel, sponge USP), GELFOAM (compressed absorbable gelatin sponge, USP),
Applicant: Pfizer, Inc.
PMA number: N18286
Supplement: S041
Product code: LMF
Generic name: Agent, absorbable hemostatic, collagen based
Decision date: 2023-05-16
Decision code: OK30
Date received: 2023-04-25
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Change of a new nitrogen flowmeter and a change in the in-process brick dimensions.