PMA P170012S022
- Device
- HEMOBLAST™ Bellows
- Applicant
- Dilon Technologies, Inc.
- PMA number
- P170012
- Supplement
- S022
- Product code
- PMX
- Decision date
- 2020-06-10
- Generic name
- Absorbable collagen hemostatic agent with thrombin
- Approval order statement
- Approval for modifications to the labeling for the Laparoscopic Applicator component of the HEMOBLAST Bellows.
Current openFDA PMA Record#
- Device
- HEMOBLAST™ Bellows
- Applicant
- Dilon Technologies, Inc.
- PMA number
- P170012
- Supplement
- S022
- Product code
- PMX
- Generic name
- Absorbable collagen hemostatic agent with thrombin
- Decision date
- 2020-06-10
- Decision code
- APPR
- Date received
- 2020-03-13
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for modifications to the labeling for the Laparoscopic Applicator component of the HEMOBLAST Bellows.