Maestro Rechargeable System
FDA premarket approval P130019/S014 · decided 2017-05-24
Approval details
- PMA number
- P130019
- Supplement
- S014
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Maestro Rechargeable System
- Generic name
- neuromodulator for obesity
- Applicant
- Reshape Lifesciences, Inc.
- Date received
- 2017-04-28
- Decision date
- 2017-05-24
- Days to decision
- 26 days
- Decision code
- APPR
- Product code
- PIM
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Roseville, MN
- Statement
- Approval for the inclusion of the Patient Transmit Coil in the Model 2504 Clinician Programmer Kit for the Maestro Rechargeable System.
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