PMA P990004S053

Device: SURGIFLO® Hemostatic Matrix Kit with Thrombin
Applicant: Ferrosan Meidcal Devices A/S
PMA number: P990004
Supplement: S053
Product code: LMF
Decision date: 2022-01-21
Generic name: Agent, absorbable hemostatic, collagen based
Approval order statement: Addition of a 8-pallet chamber at the same site for the surface sterilization of the Thrombin Kit Package of the Surgiflo® Hemostatic Matrix Kit with Thrombin.

Current openFDA PMA Record#

Device: SURGIFLO® Hemostatic Matrix Kit with Thrombin
Applicant: Ferrosan Meidcal Devices A/S
PMA number: P990004
Supplement: S053
Product code: LMF
Generic name: Agent, absorbable hemostatic, collagen based
Decision date: 2022-01-21
Decision code: OK30
Date received: 2021-12-23
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Addition of a 8-pallet chamber at the same site for the surface sterilization of the Thrombin Kit Package of the Surgiflo® Hemostatic Matrix Kit with Thrombin.