PMA P130019S017

Device
Maestro Rechargeable System
Applicant
Reshape Lifesciences, Inc.
PMA number
P130019
Supplement
S017
Product code
PIM
Decision date
2019-01-25
Classification
Neuromodulator For Obesity
Generic name
neuromodulator for obesity
Approval order statement
Approval for updates to the application firmware (v5.0A) used in the Model 2402 mobile charger.

Current openFDA PMA Record#

Device
Maestro Rechargeable System
Applicant
Reshape Lifesciences, Inc.
PMA number
P130019
Supplement
S017
Product code
PIM
Generic name
neuromodulator for obesity
Decision date
2019-01-25
Decision code
APPR
Date received
2018-02-09
Supplement type
Real-Time Process
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
Approval for updates to the application firmware (v5.0A) used in the Model 2402 mobile charger.