PMA P990009S033
- Device
- FLOSEAL HEMOSTATIC MATRIX
- Applicant
- Baxter Healthcare Corp
- PMA number
- P990009
- Supplement
- S033
- Product code
- LMF
- Decision date
- 2012-07-25
- Classification
- Agent, Absorbable Hemostatic, Collagen Based
- Generic name
- Agent, absorbable hemostatic, collagen based
- Approval order statement
- APPROVAL FOR THE FOLLOWING CHANGES TO THE FLOSEAL HEMOSTATIC MATRIX 5ML KIT CONFIGURATION: MODIFIED BOWL, PRE-FILLED SYRINGE OF SODIUM CHLORIDE SOLUTION, AND INCLUSION OF A NEEDLE-FREE VIAL ADAPTER.
Current openFDA PMA Record#
- Device
- FLOSEAL HEMOSTATIC MATRIX
- Applicant
- Baxter Healthcare Corp
- PMA number
- P990009
- Supplement
- S033
- Product code
- LMF
- Generic name
- Agent, absorbable hemostatic, collagen based
- Decision date
- 2012-07-25
- Decision code
- APPR
- Date received
- 2012-03-02
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR THE FOLLOWING CHANGES TO THE FLOSEAL HEMOSTATIC MATRIX 5ML KIT CONFIGURATION: MODIFIED BOWL, PRE-FILLED SYRINGE OF SODIUM CHLORIDE SOLUTION, AND INCLUSION OF A NEEDLE-FREE VIAL ADAPTER.