MAESTRO RECHARGEABLE SYSTEM
FDA premarket approval P130019/S005 · decided 2015-04-24
Approval details
- PMA number
- P130019
- Supplement
- S005
- 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
- 2015-03-24
- Decision date
- 2015-04-24
- Days to decision
- 31 days
- Decision code
- APPR
- Product code
- PIM
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Roseville, MN
- Statement
- APPROVAL FOR A FORMULATION CHANGE TO YOUR SILICONE MATERIAL USED IN THE TRANSMIT COILS FOR THE MAESTRO® RECHARGEABLE SYSTEM.
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