- Device
- Floseal Hemostatic Matrix
- Applicant
- Baxter Healthcare Corp
- PMA number
- P990009
- Supplement
- S065
- Product code
- PMX
- Generic name
- Absorbable collagen hemostatic agent with thrombin
- Decision date
- 2020-12-23
- Decision code
- OK30
- Date received
- 2020-11-27
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- for allowing Thrombin pouches built with the original FLOSEAL Fast Prep packaging system (P990009/S051) to be combined with syringepouches built with packaging system described in PMA supplement P990009/S063