PMA P170012S031
- Device
- HEMOBLAST® Bellows
- Applicant
- Dilon Technologies, Inc.
- PMA number
- P170012
- Supplement
- S031
- Product code
- PMX
- Decision date
- 2026-04-28
- Classification
- General, Plastic Surgery
- Generic name
- Absorbable collagen hemostatic agent with thrombin
- Approval order statement
- approval for removal of the urological exception from the currently approved indications for use.
Current openFDA PMA Record#
- Device
- HEMOBLAST® Bellows
- Applicant
- Dilon Technologies, Inc.
- PMA number
- P170012
- Supplement
- S031
- Product code
- PMX
- Generic name
- Absorbable collagen hemostatic agent with thrombin
- Decision date
- 2026-04-28
- Decision code
- APPR
- Date received
- 2025-07-11
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- approval for removal of the urological exception from the currently approved indications for use.