PMA P990009S007
- Device
- FLOSEAL MATRIX HEMOSTATIC SEALANT
- Applicant
- Baxter Healthcare Corp
- PMA number
- P990009
- Supplement
- S007
- Product code
- LMF
- Decision date
- 2001-04-10
- Classification
- Agent, Absorbable Hemostatic, Collagen Based
- Generic name
- Agent, absorbable hemostatic, collagen based
- Approval order statement
- APPROVAL FOR THE REMOVAL OF THE NEUROSURGICAL EXCLUSION FROM THE "INDICATIONS FOR USE" FOR FLOSEAL MATRIX(R) HEMOSTATIC SEALANT.
Current openFDA PMA Record#
- Device
- FLOSEAL MATRIX HEMOSTATIC SEALANT
- Applicant
- Baxter Healthcare Corp
- PMA number
- P990009
- Supplement
- S007
- Product code
- LMF
- Generic name
- Agent, absorbable hemostatic, collagen based
- Decision date
- 2001-04-10
- Decision code
- APPR
- Date received
- 2001-03-05
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL FOR THE REMOVAL OF THE NEUROSURGICAL EXCLUSION FROM THE "INDICATIONS FOR USE" FOR FLOSEAL MATRIX(R) HEMOSTATIC SEALANT.