MAESTRO RECHARGEABLE SYSTEM
FDA premarket approval P130019/S010 · decided 2016-09-20
Approval details
- PMA number
- P130019
- Supplement
- S010
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- MAESTRO RECHARGEABLE SYSTEM
- Generic name
- neuromodulator for obesity
- Applicant
- Reshape Lifesciences, Inc.
- Date received
- 2016-08-26
- Decision date
- 2016-09-20
- Days to decision
- 25 days
- Decision code
- OK30
- Product code
- PIM
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Roseville, MN
- Statement
- Material change for the flux used during in-process rework, updated inspection steps, and clarified process instructions for the Model 2002 Rechargeable Neuroregulator.
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