- Device
- Floseal Hemostatic Matrix
- Applicant
- Baxter Healthcare Corp
- PMA number
- P990009
- Supplement
- S058
- Product code
- PMX
- Generic name
- Absorbable collagen hemostatic agent with thrombin
- Decision date
- 2020-08-07
- Decision code
- APPR
- Date received
- 2019-11-22
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for the removal of the lower limit for the syringe extrusion force as a lot-release specification for the 5mL and 10mL configurations of the Floseal Hemostatic Matrix (Floseal).