AspireAssist
FDA premarket approval P150024/S010 · decided 2019-01-15
Approval details
- PMA number
- P150024
- Supplement
- S010
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Trade name
- AspireAssist
- Generic name
- Aspiration therapy system
- Applicant
- Aspire Bariatrics, Inc.
- Date received
- 2018-05-01
- Decision date
- 2019-01-15
- Days to decision
- 259 days
- Decision code
- APPR
- Product code
- OYF
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- King Of Prussia, PA
- Statement
- Approval of the revised protocol with modifications including use of local labs for blood work, changes to the minimum and maximum number of patients enrolled per site, and a revised study timeline for the post-approval study (PAS) protocol.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| Aspire Venting Tube (K182248) | Aspire Bariatrics, Inc. | 2018-11-13 |
| Aspire Introducer Needle (K180725) | Aspire Bariatrics, Inc. | 2018-07-11 |