PMA P990009S067

Device: Floseal Hemostatic Matrix
Applicant: Baxter Healthcare Corp
Product code: PMX
Decision date: 2022-03-09
Generic name: Absorbable collagen hemostatic agent with thrombin
Approval order statement: Approval for kitting an alternate 5 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
Applicant: Baxter Healthcare Corp
PMA number: P990009
Supplement: S067
Product code: PMX
Generic name: Absorbable collagen hemostatic agent with thrombin
Decision date: 2022-03-09
Decision code: APPR
Date received: 2021-09-30
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Approval for kitting an alternate 5 mL FLOSEAL kit configuration, where the human Thrombin vial will be replaced with a vial of recombinant human Thrombin (RECOTHROM).