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> DevicePMAs@therightstef
age_PMA_annotations
Documents
(2,258)
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# proj.
# Ann.
updated_at
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
0
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DevicePMAs@therightstef
P960040_S035
Approval for a fast-charge version of the device (model a155) and to correct software anomalies (models a155 and a135). The device, as modified, will be marketed under the trade name ventak vitality
768 Bytes
2020-03-03
11
0
-
DevicePMAs@therightstef
P960040_S039
Approval for the vitality 2 icd system (models t165, t167, t175, t177), model 2857 application software (version 2.2), and quick profiles disk (model 2828 version 1.0). The device is indicated for us
691 Bytes
2020-03-03
10
0
-
DevicePMAs@therightstef
P950037_S042
Approval for modifications to the selox sr pacing lead family to change the steroid dosage, maximum lead body diameter, and ring electrode base material, as well as other minor changes. The device, a
365 Bytes
2020-03-03
11
0
-
DevicePMAs@therightstef
P830045_S109
Approval for the model 3330 version6.1.1 software for the model 3650 merlin patient care system and model 3307 version 6.4.1 software for the model 3510 programmer which enables v-v timing, af suppres
538 Bytes
2020-03-03
11
0
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DevicePMAs@therightstef
P880086_S146
Approval for the zephyr xl sr model 5626 pacemaker which utilizes the xl battery model 9438 which is currently approved for use with the marketed zephyr xl dr 5826 pacemaker. The device, as modified,
320 Bytes
2020-03-03
11
0
-
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
0
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DevicePMAs@therightstef
P880086_S139
Approval for the zephyr pulse generators models: xl dr 5826, dr 5820 and sr 5620. The device is indicated in the following permanent conditions, when associated with symptoms including, but not limit
1.27 KB
2020-03-03
11
0
-
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
0
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DevicePMAs@therightstef
P880086_S114
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
11
0
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