PMA P130019S001

Device
MAESTRO RECHARGEABLE SYSTEM
Applicant
Reshape Lifesciences, Inc.
PMA number
P130019
Supplement
S001
Product code
PIM
Decision date
2015-06-02
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
S001
Product code
PIM
Generic name
neuromodulator for obesity
Decision date
2015-06-02
Decision code
APPR
Date received
2015-02-26
Supplement type
Normal 180 Day Track No User Fee
Supplement reason
Labeling Change - PAS
Approval order statement
APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.