HEMOBLAST Bellows
FDA premarket approval P170012/S011 · decided 2018-10-10
Approval details
- PMA number
- P170012
- Supplement
- S011
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- HEMOBLAST Bellows
- Generic name
- Absorbable collagen hemostatic agent with thrombin
- Applicant
- Dilon Technologies, Inc.
- Date received
- 2018-09-10
- Decision date
- 2018-10-10
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- PMX
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Newport News, VA
- Statement
- Increase batch production size during drying, implement the use of stainless steel drying trays, increase storage time of in-process device, and increase the sampling plan throughout the manufacturing process.
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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 |