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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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1 to 10 of 87 Results
productcode LWP PMA Number p Decision Date From 1/1/2018 Decision Date To 1/1/2019
 
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Device
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PMA
Number
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Decision
Date
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capsurefix mri lead Medtronic, Inc P090013 S295 12/17/2018
tendril mri low voltage active Abbott Medical P140033 S044 12/17/2018
assurity mri and endurity mri, mri activator, and ... Abbott Medical P140033 S042 12/13/2018
tendril mri low voltage leads Abbott Medical P140033 S043 12/05/2018
percepta bipolar crt-p, percepta quadripolar crt-p... MEDTRONIC Inc. P010015 S387 12/03/2018
revo mri surescan ipg and pacing system Medtronic, Inc P090013 S294 12/03/2018
consulta crt-p, percepta bipolar crt-p, percepta q... MEDTRONIC Inc. P010015 S386 11/28/2018
attain bipolar otw lv lead; consulta crt-p; percep... MEDTRONIC Inc. P010015 S384 11/19/2018
capsurefix mri lead Medtronic, Inc P090013 S292 11/19/2018
ingenio mri, vitalio mri, formio mri, essentio mri... BOSTONSCIENTIFIC P150012 S066 11/16/2018
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