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DevicePMAs@therightstef
P930022_S000
Approval for the legend plus(r) pacing system including the legend plus(r) pulse generator models 8446 and 8448; the model 9790 and 9790c programmers with the model 9891 baseline software and with the
927 Bytes
2020-03-03
9
23
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DevicePMAs@therightstef
P880086_S204
Approval for the new sustain xl pacemaker models, predicated off the victory/zephyr family of pacemaker. the device, as modified, will be marketed under the trade name sustain xl dr/sr and sustain xl
1.49 KB
2020-03-03
9
32
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DevicePMAs@therightstef
P010015_S368
Approval for an update to the indications for use to include pacing at the bundle of His. The device, as modified, will be marketed under the trade name SelectSecure MRI SureScan Lead Model 3830 and i
459 Bytes
2020-03-03
9
12
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DevicePMAs@therightstef
P150012_S000
Approval for The ImageReady MR Conditional Pacing System. The device is indicated for the treatment of the following conditions: 1) Symptomatic paroxysmal or permanent second- or third-degree AV bloc
2 KB
2020-03-03
9
44
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DevicePMAs@therightstef
P900070_S031
Approval for modifications to the epic ii/epic ii+ and epic ii hf devices. The modifications include adding a vibratory patient notifier; modifying the electrogram morphology algorithm; modifying the
1.6 KB
2020-03-03
9
24
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DevicePMAs@therightstef
P880086_S174
Approval for the accent / accent rf implantable pulse generators and anthem / anthem rf crt-ps. The device, as modified, will be marketed under the trade name accent / accent rf implantable pulse gen
1.85 KB
2020-03-03
9
35
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DevicePMAs@therightstef
P980016_S046
Approval for the medtronic entrust models d153atg, d153drg, d153vrc, d154atg, d154drg, d154vrc, medtronic model 9987 application software and the medtronic model 2696 incheck patient assistant are ind
1.91 KB
2020-03-03
9
36
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DevicePMAs@therightstef
P960040_S036
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
9
32
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DevicePMAs@therightstef
P910023_S057
Approval for the identity pulse generator model sr 5172. The device is indicated in the following permanent conditions, when associated with symptoms including, but not limited to: syncope, presyncop
1.04 KB
2020-03-03
9
26
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DevicePMAs@therightstef
P880006_S037
Approval for modifications to the epic ii/epic ii+ and epic ii hf devices. The modifications include adding a vibratory patient notifier; modifying the electrogram morphology algorithm; modifying the
1.6 KB
2020-03-03
9
25
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