PMA P130019S008
- Device
- MAESTRO RECHARGEABLE SYSTEM
- Applicant
- Reshape Lifesciences, Inc.
- PMA number
- P130019
- Supplement
- S008
- Product code
- PIM
- Decision date
- 2016-06-03
- Classification
- Neuromodulator For Obesity
- Generic name
- neuromodulator for obesity
- Approval order statement
- Changes to the software and hardware associated with the Rechargeable Neuroregulator (RNR) final assembly and circuit assembly test fixtures,
Current openFDA PMA Record#
- Device
- MAESTRO RECHARGEABLE SYSTEM
- Applicant
- Reshape Lifesciences, Inc.
- PMA number
- P130019
- Supplement
- S008
- Product code
- PIM
- Generic name
- neuromodulator for obesity
- Decision date
- 2016-06-03
- Decision code
- OK30
- Date received
- 2016-05-13
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Changes to the software and hardware associated with the Rechargeable Neuroregulator (RNR) final assembly and circuit assembly test fixtures,