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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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1 to 3 of 3 Results
productcode LTI PMA Number p Decision Date From 1/1/2021 Decision Date To 1/1/2022
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Device
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Applicant
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PMA
Number
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Decision
Date
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ORBERA® Intragastric Balloon (IGB) System Boston Scientific Corporation P140008 S023 12/21/2021
Spatz3 Adjustable Balloon System Spatz FGIA Inc. P190012 10/15/2021
ORBERA Intragastric Balloon (IGB) System Boston Scientific Corporation P140008 S022 08/12/2021
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