PMA P130019S010

Device: MAESTRO RECHARGEABLE SYSTEM
Applicant: Reshape Lifesciences, Inc.
PMA number: P130019
Supplement: S010
Product code: PIM
Decision date: 2016-09-20
Classification: Neuromodulator For Obesity
Generic name: neuromodulator for obesity
Approval order statement: Material change for the flux used during in-process rework, updated inspection steps, and clarified process instructions for the Model 2002 Rechargeable Neuroregulator.

Current openFDA PMA Record#

Device: MAESTRO RECHARGEABLE SYSTEM
Applicant: Reshape Lifesciences, Inc.
PMA number: P130019
Supplement: S010
Product code: PIM
Generic name: neuromodulator for obesity
Decision date: 2016-09-20
Decision code: OK30
Date received: 2016-08-26
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Material change for the flux used during in-process rework, updated inspection steps, and clarified process instructions for the Model 2002 Rechargeable Neuroregulator.