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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 1/1/2016 Decision Date To 1/1/2017
 
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OBALON BALLOON SYSTEM ReShape Lifesciences, Inc. P160001 S002 12/15/2016
RESHAPE INTEGRATED DUAL BALLOON SYSTEM Boston Scientific Corporation P140012 S005 10/25/2016
ETHICON ENDO-SURGERY CURVED ADJUSTABLE GASTRIC WIT... OBTECH MEDICAL GMBH P070009 S017 10/11/2016
OBALON BALLOON SYSTEM ReShape Lifesciences, Inc. P160001 09/08/2016
LAP-BAND ADJUSTABLE GASTIC BANDING SYSTEM ReShape Lifesciences, Inc. P000008 S035 05/23/2016
ORBERA INTRAGASTRIC BALLOON SYSTEM Boston Scientific Corporation P140008 S003 05/23/2016
Ethicon Endo-Surgery Curved Adjustable Gastric Ban... OBTECH MEDICAL GMBH P070009 S016 05/16/2016
LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM ReShape Lifesciences, Inc. P000008 S037 03/28/2016
LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM ReShape Lifesciences, Inc. P000008 S034 03/03/2016
ORBERA INTRAGASTRIC BALLOON SYSTEM Boston Scientific Corporation P140008 S001 03/02/2016
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