PMA P990004S052

Device: SURGIFOAM® Absorbable Gelatin Sponge, SURGIFLO® Hemostatic Matrix, SURGIFOAM® Absorbable Gelatin Powder, SURGIFOAM® Abso
Applicant: Ferrosan Meidcal Devices A/S
PMA number: P990004
Supplement: S052
Product code: LMF
Decision date: 2022-01-19
Generic name: Agent, absorbable hemostatic, collagen based
Approval order statement: Implementation of a new clean room, HVAC and utility systems at the Ferrosan manufacturing facility to be used in the production of all SURGIFOAM and SURGIFLO devices.

Current openFDA PMA Record#

Device: SURGIFOAM® Absorbable Gelatin Sponge, SURGIFLO® Hemostatic Matrix, SURGIFOAM® Absorbable Gelatin Powder, SURGIFOAM® Abso
Applicant: Ferrosan Meidcal Devices A/S
PMA number: P990004
Supplement: S052
Product code: LMF
Generic name: Agent, absorbable hemostatic, collagen based
Decision date: 2022-01-19
Decision code: OK30
Date received: 2021-12-20
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Implementation of a new clean room, HVAC and utility systems at the Ferrosan manufacturing facility to be used in the production of all SURGIFOAM and SURGIFLO devices.