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U.S. Department of Health and Human Services

Premarket Approval - PMA
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Device Name
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PMA
Number
Sort by PMA Number [0-9]
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Decision
Date
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thoratec heartmate ii ventricular assist system (lvas), thoratec ventricular assist device system Abbott Medical P060040S048 02/22/2016
acuity x4 straight (4671,4672), spiral s (4674,4675), spiral l (4677,4678) leads; sutureless sleeve & flushing tool/wire Boston Scientific Corp. P010012S398 02/22/2016
reliance 4-site lead family BOSTON SCIENTIFIC P910073S132 02/22/2016
mycare link patient monitor Medtronic, Inc. P890003S346 02/22/2016
cobas ampliprep/cobas taqman hcv test v2.0 Roche Molecular Systems, Inc. P060030S048 02/18/2016
ol1000, ol1000 sc and spinalogic bone growth stimulators DJO, LLC P910066S028 02/18/2016
edwards expandable introducer sheath set EDWARDS LIFESCIENCES, LLC. P130009S046 02/16/2016
memorygel breast implant MENTOR CORP. P030053S031 02/12/2016
memoryshape breast implants MENTOR WORLDWIDE LLC P060028S013 02/12/2016
crystalens and trulign toric posterior chamber intraocular lens Bausch & Lomb, Inc. P030002S037 02/09/2016

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