PMA P130019S013

Device: Maestro Rechargeable System
Applicant: Reshape Lifesciences, Inc.
PMA number: P130019
Supplement: S013
Product code: PIM
Decision date: 2017-03-22
Classification: Neuromodulator For Obesity
Generic name: neuromodulator for obesity
Approval order statement: Approval for changes to the incoming inspection, shelf storage, and preparation for shipment procedures for evaluating the battery of the Mobile Charger.

Current openFDA PMA Record#

Device: Maestro Rechargeable System
Applicant: Reshape Lifesciences, Inc.
PMA number: P130019
Supplement: S013
Product code: PIM
Generic name: neuromodulator for obesity
Decision date: 2017-03-22
Decision code: APPR
Date received: 2017-03-02
Supplement type: Special (Immediate Track)
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Approval for changes to the incoming inspection, shelf storage, and preparation for shipment procedures for evaluating the battery of the Mobile Charger.