PMA P130019S007

Device: MAESTRO RECHARGEABLE SYSTEM
Applicant: Reshape Lifesciences, Inc.
PMA number: P130019
Supplement: S007
Product code: PIM
Decision date: 2016-02-12
Classification: Neuromodulator For Obesity
Generic name: neuromodulator for obesity
Approval order statement: Material change for the flux used during in-process rework, the use of a 10 zone Vitronics reflow oven, machine placement of the RF shield component, clarifying process instructions, and use of the alternate Mydata assembly line for the Model 2402 Mobile Charger.

Current openFDA PMA Record#

Device: MAESTRO RECHARGEABLE SYSTEM
Applicant: Reshape Lifesciences, Inc.
PMA number: P130019
Supplement: S007
Product code: PIM
Generic name: neuromodulator for obesity
Decision date: 2016-02-12
Decision code: OK30
Date received: 2016-01-20
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, the use of a 10 zone Vitronics reflow oven, machine placement of the RF shield component, clarifying process instructions, and use of the alternate Mydata assembly line for the Model 2402 Mobile Charger.