PMA P990009S023

Device
FLOSEAL HEMOSTATIC MATRIX
Applicant
Baxter Healthcare Corp
PMA number
P990009
Supplement
S023
Product code
LMF
Decision date
2008-10-16
Classification
Agent, Absorbable Hemostatic, Collagen Based
Generic name
Agent, absorbable hemostatic, collagen based
Approval order statement
CONSTRUCTION OF AN ADDITIONAL MANUFACTURING SUITE.

Current openFDA PMA Record#

Device
FLOSEAL HEMOSTATIC MATRIX
Applicant
Baxter Healthcare Corp
PMA number
P990009
Supplement
S023
Product code
LMF
Generic name
Agent, absorbable hemostatic, collagen based
Decision date
2008-10-16
Decision code
OK30
Date received
2008-09-12
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
CONSTRUCTION OF AN ADDITIONAL MANUFACTURING SUITE.