- Device
- PerClot® Polysaccharide Hemostatic System
- Applicant
- Baxter Healthcare Corporation
- PMA number
- P210036
- Supplement
- S001
- Product code
- LMG
- Generic name
- Agent, absorbable hemostatic, non-collagen based
- Decision date
- 2024-05-08
- Decision code
- APPR
- Date received
- 2023-10-31
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for a change in the equipment utilized for granularity testing for PerClot Polysaccharide Hemostatic System