PMA P130019S005
- Device
- MAESTRO RECHARGEABLE SYSTEM
- Applicant
- Reshape Lifesciences, Inc.
- PMA number
- P130019
- Supplement
- S005
- Product code
- PIM
- Decision date
- 2015-04-24
- Classification
- Neuromodulator For Obesity
- Generic name
- neuromodulator for obesity
- Approval order statement
- APPROVAL FOR A FORMULATION CHANGE TO YOUR SILICONE MATERIAL USED IN THE TRANSMIT COILS FOR THE MAESTRO® RECHARGEABLE SYSTEM.
Current openFDA PMA Record#
- Device
- MAESTRO RECHARGEABLE SYSTEM
- Applicant
- Reshape Lifesciences, Inc.
- PMA number
- P130019
- Supplement
- S005
- Product code
- PIM
- Generic name
- neuromodulator for obesity
- Decision date
- 2015-04-24
- Decision code
- APPR
- Date received
- 2015-03-24
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR A FORMULATION CHANGE TO YOUR SILICONE MATERIAL USED IN THE TRANSMIT COILS FOR THE MAESTRO® RECHARGEABLE SYSTEM.