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PMA P990009S063

Device
Floseal Hemostatic Matrix
Applicant
Baxter Healthcare Corp
PMA number
P990009
Supplement
S063
Product code
PMX
Decision date
2020-08-28
Generic name
Absorbable collagen hemostatic agent with thrombin
Approval order statement
Addition of a previously approved packaging configuration for the 5mL and 10mL Floseal Hemostatic Matrix (FLOSEAL) device to be used with FLOSEAL Fast Prep.

Current openFDA PMA Record#

Device
Floseal Hemostatic Matrix
Applicant
Baxter Healthcare Corp
PMA number
P990009
Supplement
S063
Product code
PMX
Generic name
Absorbable collagen hemostatic agent with thrombin
Decision date
2020-08-28
Decision code
OK30
Date received
2020-08-19
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Addition of a previously approved packaging configuration for the 5mL and 10mL Floseal Hemostatic Matrix (FLOSEAL) device to be used with FLOSEAL Fast Prep.