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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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productcode LTI PMA Number p Decision Date From 1/1/2022 Decision Date To 1/1/2023
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Device
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PMA
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Decision
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ORBERA ® Intragastric Balloon (IGB) System Boston Scientific Corporation P140008 S024 10/05/2022
Obalon Balloon System ReShape Lifesciences, Inc. P160001 S047 07/18/2022
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