FDA.reportPublic FDA data

PMA P990009S043

Device
FLOSEAL HEMOSTATIC MATRIX
Applicant
Baxter Healthcare Corp
PMA number
P990009
Supplement
S043
Product code
PMX
Decision date
2016-09-14
Classification
Absorbable Collagen Hemostatic Agent With Thrombin
Generic name
Absorbable collagen hemostatic agent with thrombin
Approval order statement
Approval for labeling changes to enhance the safety of your device, including removal of the phrase spurting from bleeding types for which use of the device is described as effective in the warnings section of the labeling.

Current openFDA PMA Record#

Device
FLOSEAL HEMOSTATIC MATRIX
Applicant
Baxter Healthcare Corp
PMA number
P990009
Supplement
S043
Product code
PMX
Generic name
Absorbable collagen hemostatic agent with thrombin
Decision date
2016-09-14
Decision code
APPR
Date received
2016-08-19
Supplement type
Special (Immediate Track)
Supplement reason
Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement
Approval for labeling changes to enhance the safety of your device, including removal of the phrase spurting from bleeding types for which use of the device is described as effective in the warnings section of the labeling.