PMA P170012S025
- Device
- HEMOBLAST Bellows
- Applicant
- Dilon Technologies, Inc.
- PMA number
- P170012
- Supplement
- S025
- Product code
- PMX
- Decision date
- 2021-02-25
- Generic name
- Absorbable collagen hemostatic agent with thrombin
- Approval order statement
- Changes to the HEMOBLAST™ Bellows manufacturing facility, located in in St-Priest, France.
Current openFDA PMA Record#
- Device
- HEMOBLAST Bellows
- Applicant
- Dilon Technologies, Inc.
- PMA number
- P170012
- Supplement
- S025
- Product code
- PMX
- Generic name
- Absorbable collagen hemostatic agent with thrombin
- Decision date
- 2021-02-25
- Decision code
- OK30
- Date received
- 2021-01-27
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Changes to the HEMOBLAST™ Bellows manufacturing facility, located in in St-Priest, France.