PMA P990009S053
- Device
- Floseal NT
- Applicant
- Baxter Healthcare Corp
- PMA number
- P990009
- Supplement
- S053
- Product code
- PMX
- Decision date
- 2019-04-18
- Classification
- Absorbable Collagen Hemostatic Agent With Thrombin
- Generic name
- Absorbable collagen hemostatic agent with thrombin
- Approval order statement
- Approval for the removal of the co-packaging configuration of the 5,000 I.U. Thrombin-JMI component from the 5 mL Floseal Hemostatic Matrix.
Current openFDA PMA Record#
- Device
- Floseal NT
- Applicant
- Baxter Healthcare Corp
- PMA number
- P990009
- Supplement
- S053
- Product code
- PMX
- Generic name
- Absorbable collagen hemostatic agent with thrombin
- Decision date
- 2019-04-18
- Decision code
- APPR
- Date received
- 2019-01-22
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for the removal of the co-packaging configuration of the 5,000 I.U. Thrombin-JMI component from the 5 mL Floseal Hemostatic Matrix.