PMA P990009S076
- Device
- FLOSEAL MATRIX/FLOSEAL MATRIX HEMOSTATIC SEALANT/PROCEED HEMOSTATIC SEALANT
- Applicant
- Baxter Healthcare Corp
- PMA number
- P990009
- Supplement
- S076
- Product code
- PMX
- Decision date
- 2025-06-30
- Classification
- General, Plastic Surgery
- Generic name
- Absorbable collagen hemostatic agent with thrombin
- Approval order statement
- qualification of a new ink for use in pad printing on Floseal syringe barrels
Current openFDA PMA Record#
- Device
- FLOSEAL MATRIX/FLOSEAL MATRIX HEMOSTATIC SEALANT/PROCEED HEMOSTATIC SEALANT
- Applicant
- Baxter Healthcare Corp
- PMA number
- P990009
- Supplement
- S076
- Product code
- PMX
- Generic name
- Absorbable collagen hemostatic agent with thrombin
- Decision date
- 2025-06-30
- Decision code
- OK30
- Date received
- 2025-06-27
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- qualification of a new ink for use in pad printing on Floseal syringe barrels