PMA P990009S071

Device: Floseal Hemostatic Matrix, RT5 and RTl 0, Floseal Hemostatic Matrix, Fast Prep
Applicant: Baxter Healthcare Corp
PMA number: P990009
Supplement: S071
Product code: PMX
Decision date: 2022-11-22
Generic name: Absorbable collagen hemostatic agent with thrombin
Approval order statement: Approval to add new information to the Warnings and Adverse Events Sections of the FLOSEAL Instructions for Use.

Current openFDA PMA Record#

Device: Floseal Hemostatic Matrix, RT5 and RTl 0, Floseal Hemostatic Matrix, Fast Prep
Applicant: Baxter Healthcare Corp
PMA number: P990009
Supplement: S071
Product code: PMX
Generic name: Absorbable collagen hemostatic agent with thrombin
Decision date: 2022-11-22
Decision code: APPR
Date received: 2022-10-26
Supplement type: Special (Immediate Track)
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: Approval to add new information to the Warnings and Adverse Events Sections of the FLOSEAL Instructions for Use.