PMA P990004S074

Device: SURGIFOAM® Absorbable Gelatin Sponge
Applicant: Ferrosan Meidcal Devices A/S
PMA number: P990004
Supplement: S074
Product code: LMF
Decision date: 2025-05-27
Classification: General, Plastic Surgery
Generic name: Agent, absorbable hemostatic, collagen based
Approval order statement: expansion of the cleanroom area to be used for assembly of syringes used in SURGIFLO Intermediate at Ferrosan Medical Devices A/S (FeMD)

Current openFDA PMA Record#

Device: SURGIFOAM® Absorbable Gelatin Sponge
Applicant: Ferrosan Meidcal Devices A/S
PMA number: P990004
Supplement: S074
Product code: LMF
Generic name: Agent, absorbable hemostatic, collagen based
Decision date: 2025-05-27
Decision code: OK30
Date received: 2025-04-29
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: expansion of the cleanroom area to be used for assembly of syringes used in SURGIFLO Intermediate at Ferrosan Medical Devices A/S (FeMD)