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U.S. Department of Health and Human Services

Premarket Approval - PMA
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PMA
Number
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Decision
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glaukos istent trabecular micro-bypass stent system GLAUKOS, CORPORATION P080030S018 09/30/2016
mynxgrip vascular closure device (5f, 6f/7f) Cordis US Corporation P040044S068 09/06/2016
cobas hpv test, 240 tests; cobas hpv test, 960 tests Roche Molecular Systems, Inc. P100020S017 07/07/2016
ingevity leads BOSTONSCIENTIFIC P150012S005 06/15/2016
healon sodium hyaluronate ophthalmic viscoelastic devices (ovd), healon5 sodium hyaluronate ophthalmic viscoelastic devi Johnson & Johnson Surgical Vision, Inc. P810031S056 06/14/2016
nucleus abi541 auditory brainstem implant Cochlear Americas P000015S012 06/13/2016
cobas ampliprep/cobas taqman cytomegalovirus test Roche Molecular Systems, Inc. P110037S023 05/20/2016
access therapy patient controller,access review therapy controller MEDTRONIC Inc. P960009S173 04/29/2016
itrel ez patient programmer,synergy ez patient programmer,access therapy patient controller MEDTRONIC NEUROMODULATION P840001S242 04/29/2016
iforia 5/7 dr-t/vr-t/vr-t dx; inventra 7 dr-t/vr-t/vr-t dx; iperia 5/7 dr-t/vr-t/vr-t dx; lumax 300/340 dr/dr-t/vr/vr-t BIOTRONIK, INC. P050023S093 04/13/2016

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