PMA P990009S052
- Device
- FLOSEAL Hemostatic Matrix
- Applicant
- Baxter Healthcare Corp
- PMA number
- P990009
- Supplement
- S052
- Product code
- PMX
- Decision date
- 2019-03-22
- Classification
- Absorbable Collagen Hemostatic Agent With Thrombin
- Generic name
- Absorbable collagen hemostatic agent with thrombin
- Approval order statement
- Approval for the qualification of a second ethylene oxide sterilization cycle of the thrombin pouch assemblies.
Current openFDA PMA Record#
- Device
- FLOSEAL Hemostatic Matrix
- Applicant
- Baxter Healthcare Corp
- PMA number
- P990009
- Supplement
- S052
- Product code
- PMX
- Generic name
- Absorbable collagen hemostatic agent with thrombin
- Decision date
- 2019-03-22
- Decision code
- APPR
- Date received
- 2018-12-26
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for the qualification of a second ethylene oxide sterilization cycle of the thrombin pouch assemblies.