PMA P990004S077

Device: SURGIFOAM Absorbable Gelatin Sponge, USP
Applicant: Ferrosan Meidcal Devices A/S
PMA number: P990004
Supplement: S077
Product code: LMF
Decision date: 2026-01-28
Classification: General, Plastic Surgery
Generic name: Agent, absorbable hemostatic, collagen based
Approval order statement: process verification and performance qualification for addition of a second Syringe Assembly Machine and a second supplier of plunger rods for the syringes

Current openFDA PMA Record#

Device: SURGIFOAM Absorbable Gelatin Sponge, USP
Applicant: Ferrosan Meidcal Devices A/S
PMA number: P990004
Supplement: S077
Product code: LMF
Generic name: Agent, absorbable hemostatic, collagen based
Decision date: 2026-01-28
Decision code: OK30
Date received: 2026-01-02
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: process verification and performance qualification for addition of a second Syringe Assembly Machine and a second supplier of plunger rods for the syringes