PMA P990009S049
- Device
- FLOSEAL MATRIX/FLOSEAL MATRIX HEMOSTATIC SEALANT/PROCEED HEMOSTATIC SEALANT
- Applicant
- Baxter Healthcare Corp
- PMA number
- P990009
- Supplement
- S049
- Product code
- PMX
- Decision date
- 2017-11-09
- Classification
- Absorbable Collagen Hemostatic Agent With Thrombin
- Generic name
- Absorbable collagen hemostatic agent with thrombin
- Approval order statement
- Approval to add an alternate sterilization facility for the Thrombin Pouches to increase capacity.
Current openFDA PMA Record#
- Device
- FLOSEAL MATRIX/FLOSEAL MATRIX HEMOSTATIC SEALANT/PROCEED HEMOSTATIC SEALANT
- Applicant
- Baxter Healthcare Corp
- PMA number
- P990009
- Supplement
- S049
- Product code
- PMX
- Generic name
- Absorbable collagen hemostatic agent with thrombin
- Decision date
- 2017-11-09
- Decision code
- APPR
- Date received
- 2017-08-14
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval to add an alternate sterilization facility for the Thrombin Pouches to increase capacity.