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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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1 to 10 of 32 Results
productcode LTI PMA Number p Decision Date From 1/1/2018 Decision Date To 1/1/2019
 
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PMA
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Obalon Balloon System with Navigation Touch ReShape Lifesciences, Inc. P160001 S020 12/20/2018
Obalon Balloon Kit ReShape Lifesciences, Inc. P160001 S029 12/16/2018
LAP-BAND Adjustable Gastric Banding System ReShape Lifesciences, Inc. P000008 S044 11/30/2018
Orbera Intragastric Balloon Boston Scientific Corporation P140008 S014 11/28/2018
Obalon Touch Dispenser ReShape Lifesciences, Inc. P160001 S028 11/20/2018
Obalon Touch Dispenser ReShape Lifesciences, Inc. P160001 S024 11/07/2018
Obalon Touch Dispenser ReShape Lifesciences, Inc. P160001 S025 11/07/2018
Obalon Touch Dispenser ReShape Lifesciences, Inc. P160001 S026 11/07/2018
Obalon Balloon System ReShape Lifesciences, Inc. P160001 S008 10/25/2018
Obalon Balloon System ReShape Lifesciences, Inc. P160001 S011 10/05/2018
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