PMA P990009S050
- Device
- FLOSEAL Hemostatic Matrix/ Floseal Special Applicator Tips
- Applicant
- Baxter Healthcare Corp
- PMA number
- P990009
- Supplement
- S050
- Product code
- PMX
- Decision date
- 2017-11-01
- Classification
- Absorbable Collagen Hemostatic Agent With Thrombin
- Generic name
- Absorbable collagen hemostatic agent with thrombin
- Approval order statement
- Change of the Bacterial Endotoxin Test (BET) method to Limulus Amebocyte Lysate (LAL) Kinetic Turbidimetric Method.
Current openFDA PMA Record#
- Device
- FLOSEAL Hemostatic Matrix/ Floseal Special Applicator Tips
- Applicant
- Baxter Healthcare Corp
- PMA number
- P990009
- Supplement
- S050
- Product code
- PMX
- Generic name
- Absorbable collagen hemostatic agent with thrombin
- Decision date
- 2017-11-01
- Decision code
- OK30
- Date received
- 2017-10-02
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Change of the Bacterial Endotoxin Test (BET) method to Limulus Amebocyte Lysate (LAL) Kinetic Turbidimetric Method.