PMA P990004S080

Device
SURGIFOAM® Absorbable Gelatin Sponge
Applicant
Ferrosan Meidcal Devices A/S
PMA number
P990004
Supplement
S080
Product code
LMF
Decision date
2026-09-18
Classification
General, Plastic Surgery
Generic name
Agent, absorbable hemostatic, collagen based
Approval order statement
approval for thinning of inner tray foil

Current openFDA PMA Record#

Device
SURGIFOAM® Absorbable Gelatin Sponge
Applicant
Ferrosan Meidcal Devices A/S
PMA number
P990004
Supplement
S080
Product code
LMF
Generic name
Agent, absorbable hemostatic, collagen based
Decision date
2026-09-18
Decision code
APPR
Date received
2026-03-25
Supplement type
Normal 180 Day Track
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
approval for thinning of inner tray foil