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> DevicePMAs@therightstef
PMA_age_indications
Documents
(2,236)
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DevicePMAs@therightstef
P980016_S021
Approval for the model 2490a carelink monitor with model 2491 ddma server-resident software. The device, as modified, will be marketed under the trade name model 2490a carelink monitor and is indicat
318 Bytes
2020-03-03
11
0
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DevicePMAs@therightstef
P980016_S062
Approval for the medtronic virtuoso dr/vr models d154a wg/d154vwc implantable cardioverter defibrillators and the concerto - virtuoso v 1.0 software application model sw002. The medtronic virtuoso dr
1.81 KB
2020-03-03
11
0
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DevicePMAs@therightstef
P980023_S002
Approval for device hardware and software modifications. The device, as modified, will be marketed under the trade name mycroPhylax(Plus), Phylax XM, and TMS 1000(Plus) Tachyarrhythmia Monitoring Sys
568 Bytes
2020-03-03
11
0
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DevicePMAs@therightstef
P920015_S022
Approval for model 6726 df-1 y-adaptor/extender kit. The device is indicated to adapt two df-1 lead connectors to a single df-1 compatible connector port and/or will extend the length of a df-1 lead
291 Bytes
2020-03-03
11
0
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DevicePMAs@therightstef
P910023_S066
Approval for the identity adx models xl dr 5386 and dr 5380 pulse generators and programmer software model 3307 v4.2a. These devices are indicated as follows: implantation of identity adx models5386
1.18 KB
2020-03-03
11
0
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DevicePMAs@therightstef
P910073_S025
Approval for the Models 0144, 0145 and 0146 endocardial defibrillation leads. The device, as modified, will be marketed under the trade name ENDOTAK(R) ENDURANCE (Rx(TM)) Endocardial Defibrillation L
389 Bytes
2020-03-03
11
0
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DevicePMAs@therightstef
P980023_S023
Approval for a lead based on the kentrox sl and linox sd icd leads with 0.11 mm filaments in the lead tip conductor. The device, as modified, will be marketed under the trade name linox td implantabl
476 Bytes
2020-03-03
11
0
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DevicePMAs@therightstef
P980023_S019
Approval for modifications to the kentrox family of implantable cardioverter defibrillator (icd) leads. The devices, as modified, will be marketed under the trade names kentrox rv, kentrox rv steroid
356 Bytes
2020-03-03
11
0
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DevicePMAs@therightstef
P950022_S041
Approval to modify the shock coil on the riata st optim and riata sts optim leads and to add two new passive lead models. The devices, as modified, will be marketed under the trade name riata st opti
558 Bytes
2020-03-03
11
0
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DevicePMAs@therightstef
P960040_S000
Approval for the ventak(r) av(tm) aicd(tm) model 1810/model 1815 automatic implantable cardioverter defibrillator (aicd(tm) with the model 2833 software application. this device is indicated for use i
838 Bytes
2020-03-03
11
0
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