PerClot® Polysaccharide Hemostatic System
FDA premarket approval P210036/S007 · decided 2026-06-08
Approval details
- PMA number
- P210036
- Supplement
- S007
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- PerClot® Polysaccharide Hemostatic System
- Generic name
- Agent, absorbable hemostatic, non-collagen based
- Applicant
- Baxter Healthcare Corporation
- Date received
- 2025-12-23
- Decision date
- 2026-06-08
- Days to decision
- 167 days
- Decision code
- APPR
- Product code
- LMG
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Round Lake, IL
- 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.
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