PMA P990009S032

Device
FLOSEAL HEMOSTATIC MATRIX
Applicant
Baxter Healthcare Corp
PMA number
P990009
Supplement
S032
Product code
LMF
Decision date
2011-05-10
Classification
Agent, Absorbable Hemostatic, Collagen Based
Generic name
Agent, absorbable hemostatic, collagen based
Approval order statement
CHANGE IN AN IN-PROCESS TEST METHOD FOR THE DEVICE.

Current openFDA PMA Record#

Device
FLOSEAL HEMOSTATIC MATRIX
Applicant
Baxter Healthcare Corp
PMA number
P990009
Supplement
S032
Product code
LMF
Generic name
Agent, absorbable hemostatic, collagen based
Decision date
2011-05-10
Decision code
OK30
Date received
2011-04-06
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
CHANGE IN AN IN-PROCESS TEST METHOD FOR THE DEVICE.