PMA P990009S004
- Device
- FLOSEAL MATRIX (AKA PROCEED) HEMOSTATIC SEALANT
- Applicant
- Baxter Healthcare Corp
- PMA number
- P990009
- Supplement
- S004
- Product code
- LMF
- Decision date
- 2001-02-28
- Classification
- Agent, Absorbable Hemostatic, Collagen Based
- Generic name
- Agent, absorbable hemostatic, collagen based
- Approval order statement
- APPROVAL FOR AN INCREASE IN AN INTERMEDIATE SPECIFICATION FOR RESIDUAL GLUTARALDEHYDE FROM 20 TO 40 PPM.
Current openFDA PMA Record#
- Device
- FLOSEAL MATRIX (AKA PROCEED) HEMOSTATIC SEALANT
- Applicant
- Baxter Healthcare Corp
- PMA number
- P990009
- Supplement
- S004
- Product code
- LMF
- Generic name
- Agent, absorbable hemostatic, collagen based
- Decision date
- 2001-02-28
- Decision code
- APPR
- Date received
- 2001-01-16
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR AN INCREASE IN AN INTERMEDIATE SPECIFICATION FOR RESIDUAL GLUTARALDEHYDE FROM 20 TO 40 PPM.