PMA P990009S046
- Device
- Floseal Hemostatie Matrix
- Applicant
- Baxter Healthcare Corp
- PMA number
- P990009
- Supplement
- S046
- Product code
- PMX
- Decision date
- 2017-05-11
- Classification
- Absorbable Collagen Hemostatic Agent With Thrombin
- Generic name
- Absorbable collagen hemostatic agent with thrombin
- Approval order statement
- Modification to the in-process and final release testing of the Gelatin and Thrombin pouches.
Current openFDA PMA Record#
- Device
- Floseal Hemostatie Matrix
- Applicant
- Baxter Healthcare Corp
- PMA number
- P990009
- Supplement
- S046
- Product code
- PMX
- Generic name
- Absorbable collagen hemostatic agent with thrombin
- Decision date
- 2017-05-11
- Decision code
- OK30
- Date received
- 2017-04-17
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Modification to the in-process and final release testing of the Gelatin and Thrombin pouches.