PMA P990004S068

Device: SURGIFLO® Hemostatic Matrix, SURGIFLO® Hemostatic Matrix Kit with Thrombin
Applicant: Ferrosan Meidcal Devices A/S
PMA number: P990004
Supplement: S068
Product code: LMF
Decision date: 2024-08-22
Classification: General, Plastic Surgery
Generic name: Agent, absorbable hemostatic, collagen based
Approval order statement: introduction of one (1) new piece of equipment into the cleanroom at Ferrosan Medical Devices

Current openFDA PMA Record#

Device: SURGIFLO® Hemostatic Matrix, SURGIFLO® Hemostatic Matrix Kit with Thrombin
Applicant: Ferrosan Meidcal Devices A/S
PMA number: P990004
Supplement: S068
Product code: LMF
Generic name: Agent, absorbable hemostatic, collagen based
Decision date: 2024-08-22
Decision code: OK30
Date received: 2024-07-25
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: introduction of one (1) new piece of equipment into the cleanroom at Ferrosan Medical Devices