FDA.reportPublic FDA data

PMA P990009S070

Device
Floseal Hemostatic Matrix, RT5
Applicant
Baxter Healthcare Corp
Product code
PMX
Decision date
2023-02-02
Generic name
Absorbable collagen hemostatic agent with thrombin
Approval order statement
approval to allow kitting an alternate 10 mL FLOSEAL kit configuration, where the human Thrombin vial will be replaced with a vial of recombinant human Thrombin (RECOTHROM).

Current openFDA PMA Record#

Device
Floseal Hemostatic Matrix, RT5
Applicant
Baxter Healthcare Corp
PMA number
P990009
Supplement
S070
Product code
PMX
Generic name
Absorbable collagen hemostatic agent with thrombin
Decision date
2023-02-02
Decision code
APPR
Date received
2022-06-15
Supplement type
Normal 180 Day Track
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
approval to allow kitting an alternate 10 mL FLOSEAL kit configuration, where the human Thrombin vial will be replaced with a vial of recombinant human Thrombin (RECOTHROM).