PMA P130019S014

Device
Maestro Rechargeable System
Applicant
Reshape Lifesciences, Inc.
PMA number
P130019
Supplement
S014
Product code
PIM
Decision date
2017-05-24
Classification
Neuromodulator For Obesity
Generic name
neuromodulator for obesity
Approval order statement
Approval for the inclusion of the Patient Transmit Coil in the Model 2504 Clinician Programmer Kit for the Maestro Rechargeable System.

Current openFDA PMA Record#

Device
Maestro Rechargeable System
Applicant
Reshape Lifesciences, Inc.
PMA number
P130019
Supplement
S014
Product code
PIM
Generic name
neuromodulator for obesity
Decision date
2017-05-24
Decision code
APPR
Date received
2017-04-28
Supplement type
Real-Time Process
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
Approval for the inclusion of the Patient Transmit Coil in the Model 2504 Clinician Programmer Kit for the Maestro Rechargeable System.