PMA P170012S023
- Device
- HEMOBLAST Bellows
- Applicant
- Dilon Technologies, Inc.
- PMA number
- P170012
- Supplement
- S023
- Product code
- PMX
- Decision date
- 2020-09-11
- Generic name
- Absorbable collagen hemostatic agent with thrombin
- Approval order statement
- Approval for a change to the bioburden determination method.
Current openFDA PMA Record#
- Device
- HEMOBLAST Bellows
- Applicant
- Dilon Technologies, Inc.
- PMA number
- P170012
- Supplement
- S023
- Product code
- PMX
- Generic name
- Absorbable collagen hemostatic agent with thrombin
- Decision date
- 2020-09-11
- Decision code
- APPR
- Date received
- 2020-04-29
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for a change to the bioburden determination method.