PMA P990004S024

Device
SURGIFOAM ABSORBABLE GELATINE SPONGE, USP
Applicant
Ferrosan Meidcal Devices A/S
PMA number
P990004
Supplement
S024
Product code
LMF
Decision date
2014-07-02
Classification
Agent, Absorbable Hemostatic, Collagen Based
Generic name
Agent, absorbable hemostatic, collagen based
Approval order statement
APPROVAL FOR A MANUFACTURING (PACKAGING) SITE LOCATED AT FERROSAN MEDICAL DEVICES, KOKSOWA, POLAND.

Current openFDA PMA Record#

Device
SURGIFOAM ABSORBABLE GELATINE SPONGE, USP
Applicant
Ferrosan Meidcal Devices A/S
PMA number
P990004
Supplement
S024
Product code
LMF
Generic name
Agent, absorbable hemostatic, collagen based
Decision date
2014-07-02
Decision code
APPR
Date received
2014-04-22
Supplement type
Normal 180 Day Track No User Fee
Supplement reason
Location Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
APPROVAL FOR A MANUFACTURING (PACKAGING) SITE LOCATED AT FERROSAN MEDICAL DEVICES, KOKSOWA, POLAND.