MAESTRO RECHARGEABLE SYSTEM

Neuromodulator For Obesity

FDA Premarket Approval P130019 S007

This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.

Pre-market Approval Supplement Details

Material change for the flux used during in-process rework, the use of a 10 zone vitronics reflow oven, machine placement of the rf shield component, clarifying process instructions, and use of the alternate mydata assembly line for the model 2402 mobile charger.

DeviceMAESTRO RECHARGEABLE SYSTEM
Classification NameNeuromodulator For Obesity
Generic NameNeuromodulator For Obesity
ApplicantReShape Lifesciences, Inc.
Date Received2016-01-20
Decision Date2016-02-12
PMAP130019
SupplementS007
Product CodePIM
Advisory CommitteeGastroenterology/Urology
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address ReShape Lifesciences, Inc. 2800 Patton Road saint Paul, MN 55113

Supplemental Filings

Supplement NumberDateSupplement Type
P130019Original Filing
S019 2018-12-17 Normal 180 Day Track No User Fee
S018 2018-02-12 Real-time Process
S017 2018-02-09 Real-time Process
S016 2017-12-28 30-day Notice
S015 2017-06-08 Normal 180 Day Track No User Fee
S014 2017-04-28 Real-time Process
S013 2017-03-02 Special (immediate Track)
S012 2016-12-08 Special (immediate Track)
S011 2016-09-29 Real-time Process
S010 2016-08-26 30-day Notice
S009 2016-06-07 Normal 180 Day Track No User Fee
S008 2016-05-13 30-day Notice
S007 2016-01-20 30-day Notice
S006 2015-03-25 Real-time Process
S005 2015-03-24 Real-time Process
S004 2015-03-23 30-day Notice
S003 2015-03-20 30-day Notice
S002 2015-02-27 Normal 180 Day Track No User Fee
S001 2015-02-26 Normal 180 Day Track No User Fee

NIH GUDID Devices

Device IDPMASupp
00857334004361 P130019 000
00857334004200 P130019 000
00857334004217 P130019 000
00857334004248 P130019 000
00857334004262 P130019 000
00857334004279 P130019 000
00857334004286 P130019 000
00857334004293 P130019 000
00857334004309 P130019 000
00857334004316 P130019 000
00857334004323 P130019 000
00857334004347 P130019 000
00857334004354 P130019 000
00857334004194 P130019 000

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