PMA P140012S009

Device: Reshape Integrated Dual Balloon System
Applicant: Boston Scientific Corporation
PMA number: P140012
Supplement: S009
Product code: LTI
Decision date: 2017-04-20
Classification: Implant, Intragastric For Morbid Obesity
Generic name: IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
Approval order statement: Approval for changes to the ReShape Integrated Dual Balloon System Instructions for Use and Patient Information Guide for the ReShape Procedure.

Current openFDA PMA Record#

Device: Reshape Integrated Dual Balloon System
Applicant: Boston Scientific Corporation
PMA number: P140012
Supplement: S009
Product code: LTI
Generic name: IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
Decision date: 2017-04-20
Decision code: APPR
Date received: 2017-03-22
Supplement type: Special (Immediate Track)
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: Approval for changes to the ReShape Integrated Dual Balloon System Instructions for Use and Patient Information Guide for the ReShape Procedure.