PMA P990009S021

Device
FLOSEAL HEMOSTATIC MATRIX
Applicant
Baxter Healthcare Corp
PMA number
P990009
Supplement
S021
Product code
LMF
Decision date
2007-12-27
Classification
Agent, Absorbable Hemostatic, Collagen Based
Generic name
Agent, absorbable hemostatic, collagen based
Approval order statement
CHANGE IN EXTRUSION FORCE STABILITY LIMIT.

Current openFDA PMA Record#

Device
FLOSEAL HEMOSTATIC MATRIX
Applicant
Baxter Healthcare Corp
PMA number
P990009
Supplement
S021
Product code
LMF
Generic name
Agent, absorbable hemostatic, collagen based
Decision date
2007-12-27
Decision code
OK30
Date received
2007-11-19
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
CHANGE IN EXTRUSION FORCE STABILITY LIMIT.