PMA P990009S060

Device
Floseal Hemostatic Matrix
Applicant
Baxter Healthcare Corp
PMA number
P990009
Supplement
S060
Product code
PMX
Decision date
2020-06-02
Generic name
Absorbable collagen hemostatic agent with thrombin
Approval order statement
Change of a packaging material supplier.

Current openFDA PMA Record#

Device
Floseal Hemostatic Matrix
Applicant
Baxter Healthcare Corp
PMA number
P990009
Supplement
S060
Product code
PMX
Generic name
Absorbable collagen hemostatic agent with thrombin
Decision date
2020-06-02
Decision code
OK30
Date received
2020-05-04
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Change of a packaging material supplier.