PMA P130019S002

Device
MAESTRO RECHARGEABLE SYSTEM
Applicant
Reshape Lifesciences, Inc.
PMA number
P130019
Supplement
S002
Product code
PIM
Decision date
2015-07-24
Classification
Neuromodulator For Obesity
Generic name
neuromodulator for obesity
Approval order statement
APPROVAL OF THE POST APPROVAL STUDY PROTOCOL.

Current openFDA PMA Record#

Device
MAESTRO RECHARGEABLE SYSTEM
Applicant
Reshape Lifesciences, Inc.
PMA number
P130019
Supplement
S002
Product code
PIM
Generic name
neuromodulator for obesity
Decision date
2015-07-24
Decision code
APPR
Date received
2015-02-27
Supplement type
Normal 180 Day Track No User Fee
Supplement reason
Postapproval Study Protocol - OSB
Approval order statement
APPROVAL OF THE POST APPROVAL STUDY PROTOCOL.