PMA P990009S051
- Device
- Floseal Hemostatic Matrix
- Applicant
- Baxter Healthcare Corp
- PMA number
- P990009
- Supplement
- S051
- Product code
- PMX
- Decision date
- 2019-03-04
- Classification
- Absorbable Collagen Hemostatic Agent With Thrombin
- Generic name
- Absorbable collagen hemostatic agent with thrombin
- Approval order statement
- Approval for modifications to the 5ml and 10ml FLOSEAL Hemostatic Matrix (FLOSEAL) device kit configurations to reduce device preparation time. The modifications consist of minor changes to the device design, labeling, and packaging.
Current openFDA PMA Record#
- Device
- Floseal Hemostatic Matrix
- Applicant
- Baxter Healthcare Corp
- PMA number
- P990009
- Supplement
- S051
- Product code
- PMX
- Generic name
- Absorbable collagen hemostatic agent with thrombin
- Decision date
- 2019-03-04
- Decision code
- APPR
- Date received
- 2018-12-04
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for modifications to the 5ml and 10ml FLOSEAL Hemostatic Matrix (FLOSEAL) device kit configurations to reduce device preparation time. The modifications consist of minor changes to the device design, labeling, and packaging.