Maestro Rechargeable System
FDA premarket approval P130019/S015 · decided 2018-01-24
Approval details
- PMA number
- P130019
- Supplement
- S015
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol - OSB
- Trade name
- Maestro Rechargeable System
- Generic name
- neuromodulator for obesity
- Applicant
- Reshape Lifesciences, Inc.
- Date received
- 2017-06-08
- Decision date
- 2018-01-24
- Days to decision
- 230 days
- Decision code
- APPR
- Product code
- PIM
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Roseville, MN
- Statement
- Approval of the revised protocol for the post-approval study (PAS) protocol.
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