PMA P140012S002

Device: RESHAPE INTEGRATED DUAL BALLOON SYSTEM,RESHAPE BALLOON ASSEMBLY,RESHAPE REMOVAL CATHETER,RESHAPE VALVE SEALANT
Applicant: Boston Scientific Corporation
PMA number: P140012
Supplement: S002
Product code: LTI
Decision date: 2015-12-21
Classification: Implant, Intragastric For Morbid Obesity
Generic name: IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
Approval order statement: APPROVAL FOR 1) A NEW DELIVERY CATHETER GEN1; 2) PRODUCT PACKAGING FOR THE RESHAPE INTEGRATED DUAL BALLOON SYSTEM; 3) EXTENSION OF THE BALLOON AND DELIVERY CATHETER ASSEMBLY TO 24 MONTHS; AND 4) A NEW SUPPLIER FOR THE DELIVERY CATHETER ASSEMBLY (MEDBIO, INC., IN GRAND RAPIDS, MICHIGAN).

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: S002
Product code: LTI
Generic name: IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
Decision date: 2015-12-21
Decision code: APPR
Date received: 2015-09-28
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR 1) A NEW DELIVERY CATHETER GEN1; 2) PRODUCT PACKAGING FOR THE RESHAPE INTEGRATED DUAL BALLOON SYSTEM; 3) EXTENSION OF THE BALLOON AND DELIVERY CATHETER ASSEMBLY TO 24 MONTHS; AND 4) A NEW SUPPLIER FOR THE DELIVERY CATHETER ASSEMBLY (MEDBIO, INC., IN GRAND RAPIDS, MICHIGAN).