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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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1 to 10 of 94 Results
productcode LGW PMA Number p Decision Date From 1/1/2017 Decision Date To 1/1/2018
 
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Device
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PMA
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Decision
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Spectra WaveWriter Spinal Cord Stimulator System Boston Scientific Corp. P030017 S302 12/22/2017
Precision, Precision Spectra, Precision Novi, Prec... Boston Scientific Corp. P030017 S297 12/21/2017
Spinal Cord Stimulation Leads; Master Restore, Itr... MEDTRONIC NEUROMODULATION P840001 S385 12/14/2017
Restore, Itrel, Synergy and Intellis Spinal Cord S... MEDTRONIC NEUROMODULATION P840001 S383 12/13/2017
Master Restore, Itrel, and Intellis Spinal Cord St... MEDTRONIC NEUROMODULATION P840001 S386 12/12/2017
Proclaim Elite family of SCS IPGs Abbott Medical P010032 S134 12/09/2017
EonC and Eon Mini Neurostimulation System Abbott Medical P010032 S135 12/09/2017
Master Restore, Itrel and Intellis Spinal Cord Sti... MEDTRONIC NEUROMODULATION P840001 S382 12/06/2017
Spectra WaveWriter SCS System Boston Scientific Corp. P030017 S305 12/01/2017
Proclaim Family of Implantable Pulse Generators Abbott Medical P010032 S138 11/28/2017
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