MAESTRO RECHARGEABLE SYSTEM
FDA premarket approval P130019/S012 · decided 2016-12-22
Approval details
- PMA number
- P130019
- Supplement
- S012
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- MAESTRO RECHARGEABLE SYSTEM
- Generic name
- neuromodulator for obesity
- Applicant
- Reshape Lifesciences, Inc.
- Date received
- 2016-12-08
- Decision date
- 2016-12-22
- Days to decision
- 14 days
- Decision code
- APPR
- Product code
- PIM
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Roseville, MN
- Statement
- Approval to updated the Clinician Programmer (CP) build verification procedure to include a specific instructional step to ensure that the internet upload capability feature has been disabled.
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