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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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11 to 14 of 14 Results
productcode LTI PMA Number p Decision Date From 1/1/2016 Decision Date To 1/1/2017
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Device
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ORBERA INTRAGASTRIC BALLOON SYSTEM Boston Scientific Corporation P140008 S002 02/26/2016
LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM ReShape Lifesciences, Inc. P000008 S036 02/08/2016
RESHAPE INTEGRATED DUAL BALLOON SYSTEM, RESHAPE BA... Boston Scientific Corporation P140012 S003 01/22/2016
RESHAPE INTEGRATED DUAL BALLOON SYSTEM Boston Scientific Corporation P140012 S001 01/14/2016
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