PMA P990004S070

Device: SURGIFLO® Hemostatic Matrix, SURGIFLO® Hemostatic Matrix Kit with Thrombin, SURGIFOAM® Absorbable Gelatin Sponge, U.S.P.
Applicant: Ferrosan Meidcal Devices A/S
PMA number: P990004
Supplement: S070
Product code: LMF
Decision date: 2025-01-27
Classification: General, Plastic Surgery
Generic name: Agent, absorbable hemostatic, collagen based
Approval order statement: for the qualification of an expansion of the cleanroom capacity (Basis Expansion) at Ferrosan Medical Devices A/S (FeMD).

Current openFDA PMA Record#

Device: SURGIFLO® Hemostatic Matrix, SURGIFLO® Hemostatic Matrix Kit with Thrombin, SURGIFOAM® Absorbable Gelatin Sponge, U.S.P.
Applicant: Ferrosan Meidcal Devices A/S
PMA number: P990004
Supplement: S070
Product code: LMF
Generic name: Agent, absorbable hemostatic, collagen based
Decision date: 2025-01-27
Decision code: OK30
Date received: 2024-12-30
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: for the qualification of an expansion of the cleanroom capacity (Basis Expansion) at Ferrosan Medical Devices A/S (FeMD).