PMA P140012S004

Device: RESHAPE INTEGRATED DUAL BALLOON SYSTEM, RESHAPE BALLOON ASSEMBLY, RESHAPE REMOVAL CATHETER, RESHAPE VALVE SEALANT
Applicant: Boston Scientific Corporation
PMA number: P140012
Supplement: S004
Product code: LTI
Decision date: 2015-12-31
Classification: Implant, Intragastric For Morbid Obesity
Generic name: IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
Approval order statement: ADDITION OF VESTA, INC., AS A SECOND SOURCE SUPPLIER OF THE BALLOON SHELL (P/N 03-0238).

Current openFDA PMA Record#

Device: RESHAPE INTEGRATED DUAL BALLOON SYSTEM, RESHAPE BALLOON ASSEMBLY, RESHAPE REMOVAL CATHETER, RESHAPE VALVE SEALANT
Applicant: Boston Scientific Corporation
PMA number: P140012
Supplement: S004
Product code: LTI
Generic name: IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
Decision date: 2015-12-31
Decision code: OK30
Date received: 2015-12-01
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: ADDITION OF VESTA, INC., AS A SECOND SOURCE SUPPLIER OF THE BALLOON SHELL (P/N 03-0238).