- Device
- Floseal Hemostatic Matrix, Fast Prep, Floseal Hemostatic Matrix, RT5, Floseal NT and Floseal Hemostatic Matrix, Floseal
- Applicant
- Baxter Healthcare Corp
- PMA number
- P990009
- Supplement
- S069
- Product code
- PMX
- Generic name
- Absorbable collagen hemostatic agent with thrombin
- Decision date
- 2022-05-20
- Decision code
- OK30
- Date received
- 2022-04-22
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Replacement of the reverse osmosis (RO) pretreatment skid for the USP Purified Water System.