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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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1 to 8 of 8 Results
productcode OTE PMA Number p Decision Date From 1/1/2017 Decision Date To 1/1/2018
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PMA
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3Dimensions HOLOGIC, INC. P080003 S004 04/20/2017
Selenia Dimensions 3D System. HOLOGIC, INC. P080003 S005 05/23/2017
SENOCLAIRE GE Healthcare P130020 S001 01/05/2017
SENOGRAPHE PRISTINA 3D GE Healthcare P130020 S002 03/03/2017
Senographe Pristina 3D GE Healthcare P130020 S003 12/28/2017
MAMMOMAT INSPIRATION WITH TOMOSYNTHESIS OPTION SIEMENS MEDICAL SOLUTIONS USA, P140011 S003 03/23/2017
Mammomat Inspiration with Tomosynthesis Option / M... SIEMENS MEDICAL SOLUTIONS USA, P140011 S005 09/29/2017
ASPIRE CRISTALLE DIGITAL BREAST TOMOSYNTHESIS OPTI... FUJIFILM MEDICAL SYSTEMS U.S.A P160031 01/10/2017
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