PMA P130019S009
- Device
- MAESTRO RECHARGEABLE SYSTEM
- Applicant
- Reshape Lifesciences, Inc.
- PMA number
- P130019
- Supplement
- S009
- Product code
- PIM
- Decision date
- 2016-06-27
- Classification
- Neuromodulator For Obesity
- Generic name
- neuromodulator for obesity
- Approval order statement
- Approval of an amended protocol for the ODE Lead PMA Post-Approval Study.
Current openFDA PMA Record#
- Device
- MAESTRO RECHARGEABLE SYSTEM
- Applicant
- Reshape Lifesciences, Inc.
- PMA number
- P130019
- Supplement
- S009
- Product code
- PIM
- Generic name
- neuromodulator for obesity
- Decision date
- 2016-06-27
- Decision code
- APPR
- Date received
- 2016-06-07
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Approval order statement
- Approval of an amended protocol for the ODE Lead PMA Post-Approval Study.