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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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1 to 6 of 6 Results
productcode LTI PMA Number p Decision Date From 1/1/2015 Decision Date To 1/1/2016
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Device
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PMA
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RESHAPE INTEGRATED DUAL BALLOON SYSTEM, RESHAPE BA... Boston Scientific Corporation P140012 S004 12/31/2015
RESHAPE INTEGRATED DUAL BALLOON SYSTEM,RESHAPE BAL... Boston Scientific Corporation P140012 S002 12/21/2015
ORBERA INTRAGASTRIC BALLOON Boston Scientific Corporation P140008 08/05/2015
RESHAPE INTEGRATED DUAL BALLOON SYSTEM Boston Scientific Corporation P140012 07/28/2015
ADJUSTABLE GASTRIC BANDING SYSTEM ReShape Lifesciences, Inc. P000008 S033 05/27/2015
ETHICON ENDO-SURGERY CURVED ADJUSTABLE GASTRIC WIT... OBTECH MEDICAL GMBH P070009 S015 04/20/2015
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