PMA P140012S006

Device: RESHAPE INTEGRATED DUAL BALLOON SYSTEM
Applicant: Boston Scientific Corporation
PMA number: P140012
Supplement: S006
Product code: LTI
Decision date: 2017-01-06
Classification: Implant, Intragastric For Morbid Obesity
Generic name: IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
Approval order statement: Change Receipt inspection of packaging materials, reseal Valve Sealant packaging after inspection, and increase HEPA filtration and particulate alert and action levels.

Current openFDA PMA Record#

Device: RESHAPE INTEGRATED DUAL BALLOON SYSTEM
Applicant: Boston Scientific Corporation
PMA number: P140012
Supplement: S006
Product code: LTI
Generic name: IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
Decision date: 2017-01-06
Decision code: OK30
Date received: 2016-12-07
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Change Receipt inspection of packaging materials, reseal Valve Sealant packaging after inspection, and increase HEPA filtration and particulate alert and action levels.