FDA.reportPublic FDA data

PMA P990004S042

Device
SURGIFOAM Absorbable Gelatin Sponge U.S.P.
Applicant
Ferrosan Meidcal Devices A/S
PMA number
P990004
Supplement
S042
Product code
LMF
Decision date
2020-08-27
Generic name
Agent, absorbable hemostatic, collagen based
Approval order statement
Approval for implementation of a water sample monitoring program for the washing machines used to wash items used for the manufacturing of SURGIFOAM Absorbable Gelatin Sponge, SURGIFOAM Absorbable Gelatin Powder and SURGIFLO Hemostatic Matrix.

Current openFDA PMA Record#

Device
SURGIFOAM Absorbable Gelatin Sponge U.S.P.
Applicant
Ferrosan Meidcal Devices A/S
PMA number
P990004
Supplement
S042
Product code
LMF
Generic name
Agent, absorbable hemostatic, collagen based
Decision date
2020-08-27
Decision code
APPR
Date received
2020-07-30
Supplement type
Special (Immediate Track)
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Approval for implementation of a water sample monitoring program for the washing machines used to wash items used for the manufacturing of SURGIFOAM Absorbable Gelatin Sponge, SURGIFOAM Absorbable Gelatin Powder and SURGIFLO Hemostatic Matrix.