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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceRESHAPE INTEGRATED DUAL BALLOON SYSTEM,RESHAPE BALLOON ASSEMBLY,RESHAPE REMOVAL CATHETER,RESHAPE VALVE SEALANT
Generic NameIMPLANT, INTRAGASTRIC FOR MORBID OBESITY
ApplicantBoston Scientific Corporation
100 Boston Scientific Way
Marlboro, MA 01752
PMA NumberP140012
Supplement NumberS002
Date Received09/28/2015
Decision Date12/21/2015
Withdrawal Date07/23/2019
Product Code LTI 
Advisory Committee Gastroenterology/Urology
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
RecallsCDRH Recalls
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).
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