PMA P990009S029
- Device
- FLOSEAL HEMOSTATIC MATRIX
- Applicant
- Baxter Healthcare Corp
- PMA number
- P990009
- Supplement
- S029
- Product code
- LMF
- Decision date
- 2010-03-25
- Classification
- Agent, Absorbable Hemostatic, Collagen Based
- Generic name
- Agent, absorbable hemostatic, collagen based
- Approval order statement
- APPROVAL TO ADD A WARNING TO THE LABELING TO ADDRESS THE POTENTIAL RISK TO USERS AND PATIENTS IF SINGLE USE DEVICES ARE REUSED.
Current openFDA PMA Record#
- Device
- FLOSEAL HEMOSTATIC MATRIX
- Applicant
- Baxter Healthcare Corp
- PMA number
- P990009
- Supplement
- S029
- Product code
- LMF
- Generic name
- Agent, absorbable hemostatic, collagen based
- Decision date
- 2010-03-25
- Decision code
- APPR
- Date received
- 2010-03-05
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL TO ADD A WARNING TO THE LABELING TO ADDRESS THE POTENTIAL RISK TO USERS AND PATIENTS IF SINGLE USE DEVICES ARE REUSED.