PMA P990004S069

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: S069
Product code: LMF
Decision date: 2024-10-15
Classification: General, Plastic Surgery
Generic name: Agent, absorbable hemostatic, collagen based
Approval order statement: to inform the Agency of the requalification of the Basis 1 cleanrooms and HVAC system 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: S069
Product code: LMF
Generic name: Agent, absorbable hemostatic, collagen based
Decision date: 2024-10-15
Decision code: OK30
Date received: 2024-09-27
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: to inform the Agency of the requalification of the Basis 1 cleanrooms and HVAC system at Ferrosan Medical Devices A/S (FeMD)