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> DevicePMAs@therightstef
PMA_age_indications
Documents
(2,236)
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DevicePMAs@therightstef
P910077_S037
Approval for the ventak prizm 2 vr/dr models 1860/1861, ventak prizm vr/dr models 1850/1851/1855/1856, ventak prizm vr/dr he models 1852/1853, ventak mini iv models 1790/1793/1796 and ventak mini iii
598 Bytes
2020-03-03
11
0
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DevicePMAs@therightstef
P950022_S040
Approval for distal tip changes to the riata st optim lead family. The device, as modified, will be marketed under the trade name riata sts optim lead models 7120, 7121, 7122, 7130 and 7131, and are
344 Bytes
2020-03-03
11
0
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DevicePMAs@therightstef
P970024_S001
Approval for the Lyra(TM) ICD System (Models 2020, 2021, and 2022), Model 6200 Programmer Software, Smart Wand Programming Head Model 3009, Angepass(TM) RV Defibrillation Lead System (Model 4040, 4041
740 Bytes
2020-03-03
11
0
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DevicePMAs@therightstef
P910077_S041
Approval for changes to the indications for use and clinical study section labeling. The devices are indicated for: for icds (ventak prx, mini, vitality, ventak av and prizm): guidant icds are inten
1.24 KB
2020-03-03
11
0
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DevicePMAs@therightstef
P980050_S015
Approval for the medtronic gem iii at with app, device model 7276 and software model 9974. The device is indicated as follows: the model 7276 gem iii at with app is indicated for use in icd patients
1.69 KB
2020-03-03
11
0
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DevicePMAs@therightstef
P980016_S027
Approval for the medtronic/vitatron carelink programmer model 2090, model 2067 carelink programmer rf head, model 2290 lead analyzer, model 2292 analyzer cable, model 2091 carelink programmer modem, m
1.56 KB
2020-03-03
11
0
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DevicePMAs@therightstef
P980016_S114
Approval for removal of the contraindication: ?patients whose primary disorder is bradyarrhythmia? and for the medtronic consulta crt-d d224trk, maximo ii crt-d d284trk medtronic secura dr d224drg, m
1.65 KB
2020-03-03
11
0
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DevicePMAs@therightstef
P980016_S492
Approval for the mycarelink smart monitor used with the device. The device, as modified, will be marketed under the trade name mycarelink smart monitor andthe mycarelink heart application and is indi
639 Bytes
2020-03-03
11
0
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DevicePMAs@therightstef
P980023_S025
Approval for the lumax implantable cardioverter defibrillators (icds), models 300 vr, 340 vr, 300 vr-t, 340 vr-t, 300 dr, 340 dr, 300 dr-t, 340 dr-t, 300 hf, 340 hf, 300 hf-t and 340 hf-t and programm
628 Bytes
2020-03-03
11
0
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DevicePMAs@therightstef
P980016_S047
Approval for the models 2490g and 2490j carelink monitors and model 2491 ddma software for use with the insync sentry model 7297, insync ii protect model 7295, insync maximo model 7303, onyx vr model
473 Bytes
2020-03-03
11
0
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