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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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1 to 4 of 4 Results
productcode LTI PMA Number p Decision Date From 1/1/2023 Decision Date To 1/1/2024
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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, Endoline... Boston Scientific Corporation P140008 S025 12/14/2023
Lap-Band Adjustable Gastric Banding System ReShape Lifesciences, Inc. P000008 S048 12/12/2023
Spatz3 Adjustable Balloon System Spatz FGIA Inc. P190012 S002 02/15/2023
Spatz3 Adjustable Balloon System Spatz FGIA Inc. P190012 S003 01/23/2023
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