PerClot® Polysaccharide Hemostatic System
FDA premarket approval P210036/S008 · decided 2026-08-07
Approval details
- PMA number
- P210036
- Supplement
- S008
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process 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
- 2026-02-27
- Decision date
- 2026-08-07
- Days to decision
- 161 days
- Decision code
- APPR
- Product code
- LMG
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Round Lake, IL
- Statement
- sterilization process modifications (increase in the maximum dose specification and change in product configuration in the irradiation container) of the PerClot® Polysaccharide Hemostatic System
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