|
Device | Reshape Integrated Dual Balloon System |
Generic Name | IMPLANT, INTRAGASTRIC FOR MORBID OBESITY |
Applicant | Boston Scientific Corporation 100 Boston Scientific Way Marlborough, MA 01752 |
PMA Number | P140012 |
Supplement Number | S009 |
Date Received | 03/22/2017 |
Decision Date | 04/20/2017 |
Withdrawal Date
|
07/23/2019 |
Product Code |
LTI |
Advisory Committee |
Gastroenterology/Urology |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for changes to the ReShape Integrated Dual Balloon System Instructions for Use and Patient Information Guide for the ReShape Procedure. |