PMA P210036S004

Device: PerClot Polysaccharide Hemostatic System
Applicant: Baxter Healthcare Corporation
PMA number: P210036
Supplement: S004
Product code: LMG
Decision date: 2024-07-18
Classification: General, Plastic Surgery
Generic name: Agent, absorbable hemostatic, non-collagen based
Approval order statement: for a change to the existing PerClot Dichloroacetate (‘DCA’) test methodology to allow for a detection limit of DCA residuals

Current openFDA PMA Record#

Device: PerClot Polysaccharide Hemostatic System
Applicant: Baxter Healthcare Corporation
PMA number: P210036
Supplement: S004
Product code: LMG
Generic name: Agent, absorbable hemostatic, non-collagen based
Decision date: 2024-07-18
Decision code: OK30
Date received: 2024-06-21
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: for a change to the existing PerClot Dichloroacetate (‘DCA’) test methodology to allow for a detection limit of DCA residuals