Maestro Rechargeable System
FDA premarket approval P130019/S016 · decided 2018-01-22
Approval details
- PMA number
- P130019
- Supplement
- S016
- 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
- 2017-12-28
- Decision date
- 2018-01-22
- Days to decision
- 25 days
- Decision code
- OK30
- Product code
- PIM
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Roseville, MN
- Statement
- Change in manufacturing site for the contract manufacturer of the Rechargeable Neuroregulator.
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