MAESTRO RECHARGEABLE SYSTEM
FDA premarket approval P130019/S009 · decided 2016-06-27
Approval details
- PMA number
- P130019
- Supplement
- S009
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Trade name
- MAESTRO RECHARGEABLE SYSTEM
- Generic name
- neuromodulator for obesity
- Applicant
- Reshape Lifesciences, Inc.
- Date received
- 2016-06-07
- Decision date
- 2016-06-27
- Days to decision
- 20 days
- Decision code
- APPR
- Product code
- PIM
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Roseville, MN
- Statement
- Approval of an amended protocol for the ODE Lead PMA Post-Approval Study.
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