PMA P990009S074
- Device
- Floseal Hemostatic Matrix, Floseal with Recothrom, Floseal Hemostatic Matrix, Floseal Fast Prep
- Applicant
- Baxter Healthcare Corp
- PMA number
- P990009
- Supplement
- S074
- Product code
- PMX
- Decision date
- 2024-08-15
- Classification
- General, Plastic Surgery
- Generic name
- Absorbable collagen hemostatic agent with thrombin
- Approval order statement
- a change to the manufacturing of the cross-linked gelatin
Current openFDA PMA Record#
- Device
- Floseal Hemostatic Matrix, Floseal with Recothrom, Floseal Hemostatic Matrix, Floseal Fast Prep
- Applicant
- Baxter Healthcare Corp
- PMA number
- P990009
- Supplement
- S074
- Product code
- PMX
- Generic name
- Absorbable collagen hemostatic agent with thrombin
- Decision date
- 2024-08-15
- Decision code
- OK30
- Date received
- 2024-08-05
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- a change to the manufacturing of the cross-linked gelatin