Pathway Clinical Trial Cohort
FDA premarket approval P150024/S016 · decided 2020-04-24
Approval details
- PMA number
- P150024
- Supplement
- S016
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - PAS
- Trade name
- Pathway Clinical Trial Cohort
- Generic name
- Aspiration therapy system
- Applicant
- Aspire Bariatrics, Inc.
- Date received
- 2019-10-29
- Decision date
- 2020-04-24
- Days to decision
- 178 days
- Decision code
- APPR
- Product code
- OYF
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- King Of Prussia, PA
- Statement
- Approval including the ODE Lead PMA Post-Approval Study - Extended Follow-up of the Premarket Cohort (PATHWAY Clinical Trial) has been fulfilled.
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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 |