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RESHAPE INTEGRATED DUAL BALLOON SYSTEM,RESHAPE BALLOON ASSEMBLY,RESHAPE REMOVAL CATHETER,RESHAPE VALVE SEALANT

FDA premarket approval P140012/S002 · decided 2015-12-21

Approval details

PMA number
P140012
Supplement
S002
Supplement type
Normal 180 Day Track
Supplement reason
Change Design/Components/Specifications/Material
Trade name
RESHAPE INTEGRATED DUAL BALLOON SYSTEM,RESHAPE BALLOON ASSEMBLY,RESHAPE REMOVAL CATHETER,RESHAPE VALVE SEALANT
Generic name
IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
Applicant
Boston Scientific Corporation
Date received
2015-09-28
Decision date
2015-12-21
Days to decision
84 days
Decision code
APPR
Product code
LTI
Advisory committee
Gastroenterology, Urology
Expedited review
No
Location
Marlboro, MA
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).

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