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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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1 to 5 of 5 Results
productcode LTI PMA Number p Decision Date From 1/1/2020 Decision Date To 1/1/2021
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Device
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PMA
Number
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Decision
Date
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ORBERA Intragastric Balloon System Boston Scientific Corporation P140008 S019 12/02/2020
ORBERA Intragastric Balloon System Boston Scientific Corporation P140008 S021 10/16/2020
Obalon Balloon System ReShape Lifesciences, Inc. P160001 S046 03/30/2020
ORBERA Intragastric Balloon System Boston Scientific Corporation P140008 S016 02/13/2020
Obalon Ballon System with Navigation and Touch ReShape Lifesciences, Inc. P160001 S044 02/11/2020
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