PMA P990009S054
- Device
- Floseal Hemostatic Matrix
- Applicant
- Baxter Healthcare Corp
- PMA number
- P990009
- Supplement
- S054
- Product code
- PMX
- Decision date
- 2019-05-15
- Classification
- Absorbable Collagen Hemostatic Agent With Thrombin
- Generic name
- Absorbable collagen hemostatic agent with thrombin
- Approval order statement
- Modify the water purification system that is used to provide water for the manufacture of Floseal Hemostatic Matrix.
Current openFDA PMA Record#
- Device
- Floseal Hemostatic Matrix
- Applicant
- Baxter Healthcare Corp
- PMA number
- P990009
- Supplement
- S054
- Product code
- PMX
- Generic name
- Absorbable collagen hemostatic agent with thrombin
- Decision date
- 2019-05-15
- Decision code
- OK30
- Date received
- 2019-04-12
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Modify the water purification system that is used to provide water for the manufacture of Floseal Hemostatic Matrix.