FDA.reportPublic FDA data

PMA P990004S033

Device
SURGIFLO Hemostatic Matrix Kit w/Thrombin
Applicant
Ferrosan Meidcal Devices A/S
PMA number
P990004
Supplement
S033
Product code
LMF
Decision date
2019-02-20
Classification
Agent, Absorbable Hemostatic, Collagen Based
Generic name
Agent, absorbable hemostatic, collagen based
Approval order statement
Approval for a change to the pallet configuration for the Ethylene Oxide sterilization of the Thrombin Kit Package which is a part of the SURGIFLO Hemostatic Matrix Kit with Thrombin.

Current openFDA PMA Record#

Device
SURGIFLO Hemostatic Matrix Kit w/Thrombin
Applicant
Ferrosan Meidcal Devices A/S
PMA number
P990004
Supplement
S033
Product code
LMF
Generic name
Agent, absorbable hemostatic, collagen based
Decision date
2019-02-20
Decision code
APPR
Date received
2018-09-05
Supplement type
135 Review Track For 30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Approval for a change to the pallet configuration for the Ethylene Oxide sterilization of the Thrombin Kit Package which is a part of the SURGIFLO Hemostatic Matrix Kit with Thrombin.