PMA P170012S020
- Device
- HEMOBLAST Bellows
- Applicant
- Dilon Technologies, Inc.
- PMA number
- P170012
- Supplement
- S020
- Product code
- PMX
- Decision date
- 2019-11-07
- Classification
- Absorbable Collagen Hemostatic Agent With Thrombin
- Generic name
- Absorbable collagen hemostatic agent with thrombin
- Approval order statement
- Changes involving reorganization of the workflow in the HEMOBLAST Bellows manufacturing facility (St-Priest, France), mainly for the purpose of efficientlyutilizing the fixed space in the facility.
Current openFDA PMA Record#
- Device
- HEMOBLAST Bellows
- Applicant
- Dilon Technologies, Inc.
- PMA number
- P170012
- Supplement
- S020
- Product code
- PMX
- Generic name
- Absorbable collagen hemostatic agent with thrombin
- Decision date
- 2019-11-07
- Decision code
- OK30
- Date received
- 2019-10-08
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Changes involving reorganization of the workflow in the HEMOBLAST Bellows manufacturing facility (St-Priest, France), mainly for the purpose of efficientlyutilizing the fixed space in the facility.