PMA P990009S038
- Device
- FLOSEAL HEMOSTATIC MATRIX
- Applicant
- Baxter Healthcare Corp
- PMA number
- P990009
- Supplement
- S038
- Product code
- LMF
- Decision date
- 2013-12-24
- Classification
- Agent, Absorbable Hemostatic, Collagen Based
- Generic name
- Agent, absorbable hemostatic, collagen based
- Approval order statement
- CHANGE TO THE MATERIAL OF A COMPONENT IN THE FLOSEAL KIT.
Current openFDA PMA Record#
- Device
- FLOSEAL HEMOSTATIC MATRIX
- Applicant
- Baxter Healthcare Corp
- PMA number
- P990009
- Supplement
- S038
- Product code
- LMF
- Generic name
- Agent, absorbable hemostatic, collagen based
- Decision date
- 2013-12-24
- Decision code
- OK30
- Date received
- 2013-11-25
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- CHANGE TO THE MATERIAL OF A COMPONENT IN THE FLOSEAL KIT.