FDA.reportPublic FDA data

PMA P990004S036

Device
SURGIFOAM Absorbable Gelatin Sponge, U.S.P.
Applicant
Ferrosan Meidcal Devices A/S
PMA number
P990004
Supplement
S036
Product code
LMF
Decision date
2019-10-30
Classification
Agent, Absorbable Hemostatic, Collagen Based
Generic name
Agent, absorbable hemostatic, collagen based
Approval order statement
Approval for an update to the labeling within the Adverse Events section to strengthen information on adverse reactions related to unapproved uses for catheter embolization.

Current openFDA PMA Record#

Device
SURGIFOAM Absorbable Gelatin Sponge, U.S.P.
Applicant
Ferrosan Meidcal Devices A/S
PMA number
P990004
Supplement
S036
Product code
LMF
Generic name
Agent, absorbable hemostatic, collagen based
Decision date
2019-10-30
Decision code
APPR
Date received
2019-10-01
Supplement type
Special (Immediate Track)
Supplement reason
Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement
Approval for an update to the labeling within the Adverse Events section to strengthen information on adverse reactions related to unapproved uses for catheter embolization.