HEMOBLAST Bellows
FDA premarket approval P170012/S029 · decided 2024-11-06
Approval details
- PMA number
- P170012
- Supplement
- S029
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- HEMOBLAST Bellows
- Generic name
- Absorbable collagen hemostatic agent with thrombin
- Applicant
- Dilon Technologies, Inc.
- Date received
- 2024-08-08
- Decision date
- 2024-11-06
- Days to decision
- 90 days
- Decision code
- APPR
- Product code
- PMX
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Newport News, VA
- Statement
- Approval for removal of the neurosurgical exception from the currently approved indications for use and modification of the name of the approved HEMOBLAST Bellows Laparoscopic Applicator to the HEMOBLAST Bellows 35 cm Nozzle Extension.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| DILON 6800 ACELLA (ACELLA) (K110384) | Dilon Technologies, Inc. | 2011-05-03 |
| DILON 2000, MODEL 2000-6X8 AND DILON 2000, MODEL 2000-5X5 (K984466) | Dilon Technologies, Inc. | 1999-03-16 |