PMA P990004S073

Device
SURGIFLO™ Hemostatic Matrix Kit with Thrombin
Applicant
Ferrosan Meidcal Devices A/S
PMA number
P990004
Supplement
S073
Product code
LMF
Decision date
2025-07-09
Classification
General, Plastic Surgery
Generic name
Agent, absorbable hemostatic, collagen based
Approval order statement
Approval for a line extension of 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
S073
Product code
LMF
Generic name
Agent, absorbable hemostatic, collagen based
Decision date
2025-07-09
Decision code
APPR
Date received
2025-04-10
Supplement type
Normal 180 Day Track
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
Approval for a line extension of SURGIFLO™ Hemostatic Matrix Kit with Thrombin