FDA.reportPublic FDA data

PMA P990004S043

Device
SURGIFOAM Absorbable Gelatin Sponge, U.S.P.
Applicant
Ferrosan Meidcal Devices A/S
PMA number
P990004
Supplement
S043
Product code
LMF
Decision date
2020-09-25
Generic name
Agent, absorbable hemostatic, collagen based
Approval order statement
Change of the washing program in two washing machines used for cleaning ancillary equipment used in the manufacturing of SURGIFLO Hemostatic Matrix and SURGIFLO Hemostatic Matrix with Thrombin products.

Current openFDA PMA Record#

Device
SURGIFOAM Absorbable Gelatin Sponge, U.S.P.
Applicant
Ferrosan Meidcal Devices A/S
PMA number
P990004
Supplement
S043
Product code
LMF
Generic name
Agent, absorbable hemostatic, collagen based
Decision date
2020-09-25
Decision code
OK30
Date received
2020-08-26
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Change of the washing program in two washing machines used for cleaning ancillary equipment used in the manufacturing of SURGIFLO Hemostatic Matrix and SURGIFLO Hemostatic Matrix with Thrombin products.