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> DevicePMAs@therightstef
age_PMA_annotations
Documents
(2,258)
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# proj.
# Ann.
updated_at
DevicePMAs@therightstef
P920015_S039
Approval for a single-defibrillation-coil version of the fda approved sprint quattro model 6947 dual-defibrillation ?coil active-fixation right ventricular lead. The device, as modified, will be mark
380 Bytes
2020-03-03
11
0
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DevicePMAs@therightstef
P910073_S039
Approval for modified active fixation defibrillation leads. The device, as modified, will be marketed under the trade names endotak reliance and reliance/s leads and is indicated for pacing and rate-
324 Bytes
2020-03-03
10
0
-
DevicePMAs@therightstef
P910023_S065
Approval for the epic plus dr/vr device with model 3307 version 4.3a programmer software. The device, as modified, will be marketed under the trade name st. jude medical epic plus vr/dr implantable c
707 Bytes
2020-03-03
11
0
-
DevicePMAs@therightstef
P980016_S037
Approval to modify the marquis vr and dr systems to provide increased energy output (35j). The devices will be used with the following application software versions: model 9978 version 1.0 applicatio
711 Bytes
2020-03-03
10
0
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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
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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
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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
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
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
-
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