PMA P990009S073
- Device
- Floseal Hemostatic Matrix
- Applicant
- Baxter Healthcare Corp
- Product code
- PMX
- Decision date
- 2024-01-10
- Generic name
- Absorbable collagen hemostatic agent with thrombin
- Approval order statement
- change in automation in the syringe filling, syringe capping and torqueing steps
Current openFDA PMA Record#
- Device
- Floseal Hemostatic Matrix
- Applicant
- Baxter Healthcare Corp
- PMA number
- P990009
- Supplement
- S073
- Product code
- PMX
- Generic name
- Absorbable collagen hemostatic agent with thrombin
- Decision date
- 2024-01-10
- Decision code
- OK30
- Date received
- 2023-12-13
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- change in automation in the syringe filling, syringe capping and torqueing steps