PMA P140008S001

Device: ORBERA INTRAGASTRIC BALLOON SYSTEM
Applicant: Boston Scientific Corporation
PMA number: P140008
Supplement: S001
Product code: LTI
Decision date: 2016-03-02
Classification: Implant, Intragastric For Morbid Obesity
Generic name: IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
Approval order statement: Approval for the change in venders of manufacturing materials used to mold components of the ORBERA Intragastric Balloon System.

Current openFDA PMA Record#

Device: ORBERA INTRAGASTRIC BALLOON SYSTEM
Applicant: Boston Scientific Corporation
PMA number: P140008
Supplement: S001
Product code: LTI
Generic name: IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
Decision date: 2016-03-02
Decision code: APPR
Date received: 2015-08-31
Supplement type: 135 Review Track For 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Approval for the change in venders of manufacturing materials used to mold components of the ORBERA Intragastric Balloon System.