• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Premarket Approval (PMA)

  • Print
  • Share
  • E-mail
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC

New Search Back to Search Results
Note: 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.
Classification Nameneuromodulator for obesity
Generic Nameneuromodulator for obesity
ReShape Lifesciences, Inc.
2800 patton road
saint paul, MN 55113
PMA NumberP130019
Supplement NumberS010
Date Received08/26/2016
Decision Date09/20/2016
Product Code
PIM[ Registered Establishments with PIM ]
Advisory Committee Gastroenterology/Urology
Supplement Type30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Material change for the flux used during in-process rework, updated inspection steps, and clarified process instructions for the Model 2002 Rechargeable Neuroregulator.