PMA P130019
- Device
- Maestro Rechargeable System
- Applicant
- Reshape Lifesciences, Inc.
- PMA number
- P130019
- Supplement
- S019
- Product code
- PIM
- Decision date
- 2019-02-15
- Classification
- Neuromodulator For Obesity
- Generic name
- neuromodulator for obesity
- Approval order statement
- Approval of the revised protocol which includes modification to the follow-up schedule for the post-approval study (PAS) protocol.
Current openFDA PMA Record#
- Device
- Maestro Rechargeable System
- Applicant
- Reshape Lifesciences, Inc.
- PMA number
- P130019
- Supplement
- S019
- Product code
- PIM
- Generic name
- neuromodulator for obesity
- Decision date
- 2019-02-15
- Decision code
- APPR
- Date received
- 2018-12-17
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Approval order statement
- Approval of the revised protocol which includes modification to the follow-up schedule for the post-approval study (PAS) protocol.