PMA P130019S012

Device: MAESTRO RECHARGEABLE SYSTEM
Applicant: Reshape Lifesciences, Inc.
PMA number: P130019
Supplement: S012
Product code: PIM
Decision date: 2016-12-22
Classification: Neuromodulator For Obesity
Generic name: neuromodulator for obesity
Approval order statement: Approval to updated the Clinician Programmer (CP) build verification procedure to include a specific instructional step to ensure that the internet upload capability feature has been disabled.

Current openFDA PMA Record#

Device: MAESTRO RECHARGEABLE SYSTEM
Applicant: Reshape Lifesciences, Inc.
PMA number: P130019
Supplement: S012
Product code: PIM
Generic name: neuromodulator for obesity
Decision date: 2016-12-22
Decision code: APPR
Date received: 2016-12-08
Supplement type: Special (Immediate Track)
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Approval to updated the Clinician Programmer (CP) build verification procedure to include a specific instructional step to ensure that the internet upload capability feature has been disabled.