PMA P130019S016
- Device
- Maestro Rechargeable System
- Applicant
- Reshape Lifesciences, Inc.
- PMA number
- P130019
- Supplement
- S016
- Product code
- PIM
- Decision date
- 2018-01-22
- Classification
- Neuromodulator For Obesity
- Generic name
- neuromodulator for obesity
- Approval order statement
- Change in manufacturing site for the contract manufacturer of the Rechargeable Neuroregulator.
Current openFDA PMA Record#
- Device
- Maestro Rechargeable System
- Applicant
- Reshape Lifesciences, Inc.
- PMA number
- P130019
- Supplement
- S016
- Product code
- PIM
- Generic name
- neuromodulator for obesity
- Decision date
- 2018-01-22
- Decision code
- OK30
- Date received
- 2017-12-28
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Change in manufacturing site for the contract manufacturer of the Rechargeable Neuroregulator.