PMA P990009S061
- Device
- Floseal Hemostatic Matrix
- Applicant
- Baxter Healthcare Corp
- Product code
- PMX
- Decision date
- 2020-12-11
- Generic name
- Absorbable collagen hemostatic agent with thrombin
- Approval order statement
- Allow Recothrom® standalone Thrombin to be used with the FLOSEAL NT.
Current openFDA PMA Record#
- Device
- Floseal Hemostatic Matrix
- Applicant
- Baxter Healthcare Corp
- PMA number
- P990009
- Supplement
- S061
- Product code
- PMX
- Generic name
- Absorbable collagen hemostatic agent with thrombin
- Decision date
- 2020-12-11
- Decision code
- APPR
- Date received
- 2020-06-09
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Allow Recothrom® standalone Thrombin to be used with the FLOSEAL NT.