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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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1 to 6 of 6 Results
productcode EZY 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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AMS 800™ Artificial Urinary Sphincter (AUS) with a... Boston Scientific Corp. P000053 S128 11/14/2022
AMS 800™ Artificial Urinary Sphincter (AUS) with a... Boston Scientific Corp. P000053 S127 09/01/2022
AMS 800 Artificial Urinary Sphincter, AMS 800 Arti... Boston Scientific Corp. P000053 S126 07/06/2022
AMS 800™ Artificial Urinary Sphincter, AMS 800™ Ar... Boston Scientific Corp. P000053 S125 04/20/2022
AMS 800™ Artificial Urinary Sphincter, AMS 800™ Ar... Boston Scientific Corp. P000053 S124 04/01/2022
AMS 800 Artificial Urinary Sphincter with InhibiZo... Boston Scientific Corp. P000053 S123 03/07/2022
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