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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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1 to 10 of 82 Results
productcode LWP 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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Attain Bipolar OTW Lead & Attain OTW LV Lead MEDTRONIC Inc. P010015 S316 12/19/2016
ATTAIN BIPOLAR OTW LEAD, ATTAIN OTW LV LEAD, CONSU... MEDTRONIC Inc. P010015 S313 12/14/2016
REVO MRI SURESCAN IPG AND CAPSUREFIX MRI LEAD Medtronic, Inc P090013 S241 12/14/2016
DISPOSABLE EPG COVER/DISPOSABLE POUCH MEDTRONIC CARDIAC RHYTHM DISEA P820003 S137 12/14/2016
ESSENTIO MRI Models L110, L111, L131; BOSTONSCIENTIFIC P150012 S020 12/12/2016
INGEVITY BOSTONSCIENTIFIC P150012 S019 12/07/2016
ESSENTIO MRI, PROPONENT MRI, ACCOLADE MRI BOSTONSCIENTIFIC P150012 S018 11/30/2016
Consulta, Syncra, Viva CRT-P MEDTRONIC Inc. P010015 S308 11/17/2016
REVO MRI SURESCAN IPG Medtronic, Inc P090013 S235 11/17/2016
Revo MRI SureScan IPG RVDR01 Medtronic, Inc P090013 S239 11/10/2016
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