PMA P130019S003

Device
MAESTRO RECHARGEABLE SYSTEM
Applicant
Reshape Lifesciences, Inc.
PMA number
P130019
Supplement
S003
Product code
PIM
Decision date
2015-04-22
Classification
Neuromodulator For Obesity
Generic name
neuromodulator for obesity
Approval order statement
ACCEPTANCE OF THE ADDITION OF AN IN PROCESS MANUFACTURING TOOL.

Current openFDA PMA Record#

Device
MAESTRO RECHARGEABLE SYSTEM
Applicant
Reshape Lifesciences, Inc.
PMA number
P130019
Supplement
S003
Product code
PIM
Generic name
neuromodulator for obesity
Decision date
2015-04-22
Decision code
OK30
Date received
2015-03-20
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
ACCEPTANCE OF THE ADDITION OF AN IN PROCESS MANUFACTURING TOOL.