- Device
- FLOSEAL HEMOSTATIC MATRIX
- Applicant
- Baxter Healthcare Corp
- PMA number
- P990009
- Supplement
- S044
- Product code
- PMX
- Generic name
- Absorbable collagen hemostatic agent with thrombin
- Decision date
- 2017-02-10
- Decision code
- APPR
- Date received
- 2016-11-02
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for modifications to the device design, material, labeling, and packaging, including: replacement of the 10 mL syringe assembly to align with the current 5 mL syringe design, removal of bowel for thrombin, removal of thrombin stickers, removal of malleable tip applicator (10 mL configuration only), removal of luer connector (10 mL configuration only), modification to the needle-free vial access device (VAD), incorporation of thrombin pouch assembly, modification of diluent container, removal of plastic component tray, modification to kit box (5 mL configuration only), and labeling modifications corresponding to the aforementioned modifications.