- Device
- Floseal Hemostatic Matrix (FLOSEAL)
- Applicant
- Baxter Healthcare Corp
- PMA number
- P990009
- Supplement
- S068
- Product code
- PMX
- Generic name
- Absorbable collagen hemostatic agent with thrombin
- Decision date
- 2021-12-10
- Decision code
- OK30
- Date received
- 2021-11-23
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Addition of an alternate bottom web film for the non-contacting packaging of the Gelatin Syringe and Thrombin pouches in the 5mL and 10 mL Floseal Hemostatic Matrix device.