FDA.reportPublic FDA data

PMA P990009S045

Device
FLOSEAL MATRIX HEMOSTATIC SEALANT
Applicant
Baxter Healthcare Corp
PMA number
P990009
Supplement
S045
Product code
PMX
Decision date
2017-01-04
Classification
Absorbable Collagen Hemostatic Agent With Thrombin
Generic name
Absorbable collagen hemostatic agent with thrombin
Approval order statement
Approval for modification to the Instructions for Use to add clarity that the removal of excess product is done to avoid excessive inflammatory reaction, adhesion and/or granuloma formation.

Current openFDA PMA Record#

Device
FLOSEAL MATRIX HEMOSTATIC SEALANT
Applicant
Baxter Healthcare Corp
PMA number
P990009
Supplement
S045
Product code
PMX
Generic name
Absorbable collagen hemostatic agent with thrombin
Decision date
2017-01-04
Decision code
APPR
Date received
2016-12-05
Supplement type
Special (Immediate Track)
Supplement reason
Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement
Approval for modification to the Instructions for Use to add clarity that the removal of excess product is done to avoid excessive inflammatory reaction, adhesion and/or granuloma formation.