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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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21 to 30 of 79 Results
productcode NVZ PMA Number p Decision Date From 1/1/2016 Decision Date To 1/1/2017
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Device
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PMA
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Advisa MRI DR & SR Surescan Implantable Pulse Gene... MEDTRONIC Inc. P980035 S464 09/07/2016
Elite, Elite II, Minuet, Preva, Preva D, Prodigy, ... Medtronic, Inc. P890003 S358 09/06/2016
Kappa 400 MEDTRONIC Inc. P970012 S099 09/06/2016
Adapta, Advisa, AT500, EnPulse, EnRhythm, Kappa 60... MEDTRONIC Inc. P980035 S469 09/06/2016
Diva family(includes Diamond II, Ruby II, Topaz II... MEDTRONIC Inc. P990001 S122 09/06/2016
Adapta, Versa, Sensia IPG ADDR01, ADDR03, ADDR06, ... MEDTRONIC Inc. P980035 S473 09/01/2016
Adapta, Versa, Sensia IPG ADDR01, ADDR03, ADDR06, ... MEDTRONIC Inc. P980035 S472 08/16/2016
MEDTRONIC CARELINK ENCORE 29901 PROGRAMMER Medtronic, Inc. P890003 S360 08/11/2016
MYCARELINK PATIENT MONITOR, MYCARELINK READER FIEL... Medtronic, Inc. P890003 S362 08/10/2016
ADVISA DR IPG; DR MRI IPG; SR MRI IPG MEDTRONIC Inc. P980035 S467 07/20/2016
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