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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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1 to 10 of 14 Results
productcode LTI PMA Number p Decision Date From 1/1/2017 Decision Date To 1/1/2018
 
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PMA
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ReShape Integrated Dual Balloon System Boston Scientific Corporation P140012 S011 10/26/2017
Lap-Band Adjustable Gastric Banding System ReShape Lifesciences, Inc. P000008 S039 10/02/2017
Orbera Intragastric Balloon Boston Scientific Corporation P140008 S007 08/21/2017
OBALON BALLOON SYSTEM ReShape Lifesciences, Inc. P160001 S001 07/19/2017
ReShape Integrated Dual Ballon System Boston Scientific Corporation P140012 S010 06/27/2017
Orbera Intragastric Balloon System Boston Scientific Corporation P140008 S006 06/06/2017
ORBERA Intragastric Balloon System Boston Scientific Corporation P140008 S005 05/01/2017
OBALON BALLOON SYSTEM ReShape Lifesciences, Inc. P160001 S003 04/25/2017
Reshape Integrated Dual Balloon System Boston Scientific Corporation P140012 S009 04/20/2017
LAP-BAND Adjustable Gastric Banding System ReShape Lifesciences, Inc. P000008 S038 03/23/2017
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