PMA P210036

Device: PerClot® Polysaccharide Hemostatic System
Applicant: Baxter Healthcare Corporation
Product code: LMG
Decision date: 2026-06-08
Generic name: Agent, absorbable hemostatic, non-collagen based
Approval order statement: Approval for the transfer of production of the PerClot Absorbable Hemostatic Powder to an alternate manufacturing site, Beijing Huan Qiu Li Kang Biotech Co., Ltd., (HQLK) in Beijing, China.

Current openFDA PMA Record#

Device: PerClot® Polysaccharide Hemostatic System
Applicant: Baxter Healthcare Corporation
PMA number: P210036
Supplement: S007
Product code: LMG
Generic name: Agent, absorbable hemostatic, non-collagen based
Decision date: 2026-06-08
Decision code: APPR
Date received: 2025-12-23
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Location Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Approval for the transfer of production of the PerClot Absorbable Hemostatic Powder to an alternate manufacturing site, Beijing Huan Qiu Li Kang Biotech Co., Ltd., (HQLK) in Beijing, China.