PMA P990009

Device: Floseal Hemostatic Matrix, Floseal with Recothrom; Floseal Hemostatic Matrix, Floseal Fast Prep; 3 Floseal Hemostatic Ma
Applicant: Baxter Healthcare Corp
PMA number: P990009
Supplement: S071
Product code: PMX
Decision date: 2025-11-13
Generic name: Absorbable collagen hemostatic agent with thrombin
Approval order statement: implementation of an automated powder filling system and the associated cleanroom expansion to accommodate the new system

Current openFDA PMA Record#

Device: Floseal Hemostatic Matrix, Floseal with Recothrom; Floseal Hemostatic Matrix, Floseal Fast Prep; 3 Floseal Hemostatic Ma
Applicant: Baxter Healthcare Corp
PMA number: P990009
Supplement: S077
Product code: PMX
Generic name: Absorbable collagen hemostatic agent with thrombin
Decision date: 2025-11-13
Decision code: OK30
Date received: 2025-10-10
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: implementation of an automated powder filling system and the associated cleanroom expansion to accommodate the new system