PMA P990009S034
- Device
- FLOSEAL HEMOSTATIC MATRIX
- Applicant
- Baxter Healthcare Corp
- PMA number
- P990009
- Supplement
- S034
- 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 MATRIX10ML KIT CONFIGURATION: INCLUSION OF MALLEABLE TIP; APPLICATOR; MODIFIED BOWL; PRE-FILLED SYRINGE OF SODIUM CHLORIDE SOLUTION; VIAL OF THROMBIN (5000 UNITS); AND INCLUSION OF A NEEDLE-FREE VIAL ADAPTER.
Current openFDA PMA Record#
- Device
- FLOSEAL HEMOSTATIC MATRIX
- Applicant
- Baxter Healthcare Corp
- PMA number
- P990009
- Supplement
- S034
- Product code
- LMF
- Generic name
- Agent, absorbable hemostatic, collagen based
- Decision date
- 2012-07-25
- Decision code
- APPR
- Date received
- 2012-03-06
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR THE FOLLOWING CHANGES TO THE FLOSEAL HEMOSTATIC MATRIX10ML KIT CONFIGURATION: INCLUSION OF MALLEABLE TIP; APPLICATOR; MODIFIED BOWL; PRE-FILLED SYRINGE OF SODIUM CHLORIDE SOLUTION; VIAL OF THROMBIN (5000 UNITS); AND INCLUSION OF A NEEDLE-FREE VIAL ADAPTER.