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> DevicePMAs@therightstef
PMA_age_indications
Documents
(2,236)
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DevicePMAs@therightstef
P900061_S044
Approval for the general use indication for implantable cardioverter defibrillator models micro jewel 7221, micro jewel ii 7223, gem dr 7271, gem ii dr 7273 and gem ii vr 7229 and are indicated to pro
339 Bytes
2020-03-03
11
0
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DevicePMAs@therightstef
P910023_S053
Approval for the use of a new battery model (wgl 2150) for the legally marketed st. jude mepro md (models v-186f and v-1 dr (model v-230hv) and p 5 vr/dr implantable cardioverter defibrillators (model
1.39 KB
2020-03-03
11
0
-
DevicePMAs@therightstef
P980016_S536
Approval of the evera mri xt/s dr and vr implantable cardioverterdefibrillator devices and programmer application software model sw033 as well as extension of mr conditional labeling and use for sprin
825 Bytes
2020-03-03
11
0
-
DevicePMAs@therightstef
P910073_S026
The device is indicated for use to provide pacing and rate-sensing and deliver cardioversion and defibrillation shocks for AICS automatic implantable cardioverter defibrillator systems.
185 Bytes
2020-03-03
11
0
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DevicePMAs@therightstef
P920015_S151
Approval of the evera mri xt/s dr and vr implantable cardioverterdefibrillator devices and programmer application software model sw033 as well as extension of mr conditional labeling and use for sprin
825 Bytes
2020-03-03
11
0
-
DevicePMAs@therightstef
P980016_S033
Approval for the model 2490d/e carelink monitors and the server-based model 2491 device data management software application (ddma) which are indicated for use by the patient to interrogate their impl
315 Bytes
2020-03-03
11
0
-
DevicePMAs@therightstef
P900061_S055
Approval for the model 2490d/e carelink monitors and the server-based model 2491 device data management software application (ddma) which are indicated for use by the patient to interrogate their impl
315 Bytes
2020-03-03
11
0
-
DevicePMAs@therightstef
P940024_S000
Approval for the guardian(tm) atp ii model 4211 implantable cardioverter/defibrillator system. the guardian(tm) atp ii model 4211 implantable cardioverter defibrillator hereafter referred to as the 42
1.28 KB
2020-03-03
11
0
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DevicePMAs@therightstef
P900061_S049
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
P980050_S004
Approval for labeling for the model 7276 gem iii at implantable defibrillator which reflects the "af only" indication (i. e., indicated for use in icd patients with atrial tachyarrhythmias, or who are
260 Bytes
2020-03-03
11
0
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