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source DB |
source ID
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text
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size
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updated at |
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# proj.
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# Ann.
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updated_at |
| DevicePMAs@therightstef |
P910023_S047 |
Approval for the photon(tm) dr icd system programmer software, model ac-ip is-1 receptable plug, and model 442-2 torque driver/torque wrench. The device is indicated for use in patients with a histor |
821 Bytes |
2020-03-03 |
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11 |
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0 |
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| DevicePMAs@therightstef |
P910023_S061 |
Approval for a downsized version of the photon udr/vr device. The device, as modified, will be marketed under the trade name st. jude medical epic vr/dr implantable cardioverter defibrillators (model |
380 Bytes |
2020-03-03 |
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10 |
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0 |
-
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| DevicePMAs@therightstef |
P980023_S000 |
Approval for the Phylax Implantable Cardioverter Defibrillator (ICD) System: a) ICD PUlse Generator - Phylax XM ICD, model number 121491; Phylax XM Active Housing ICD, model number 121492; Phylax XM R |
1.5 KB |
2020-03-03 |
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11 |
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0 |
-
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| DevicePMAs@therightstef |
P830060_S000 |
Approval for the Automatic Implantable Cardioverter Defibrillator (AICD). The device is indicated for the treatment of ventricular tachycardia and ventricular fibrillation in those patients who are a |
855 Bytes |
2020-03-03 |
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11 |
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0 |
-
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| DevicePMAs@therightstef |
P970024_S000 |
The device is indicated for use in patients who are at risk of sudden death due to ventricular arrhythmias and have experienced one of the following situations: 1) Survival of at least one episode of |
367 Bytes |
2020-03-03 |
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11 |
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0 |
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| DevicePMAs@therightstef |
P950022_S027 |
Approval for: 1) modifications to the riata st models 7000, 7001 and 7002 active-fixation defibrillation leads to change the geometric profile of the inner coil and add white pigment to the medical ad |
920 Bytes |
2020-03-03 |
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11 |
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0 |
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| DevicePMAs@therightstef |
P900061_S047 |
Approval for modifications to the connector modules and connector assembly. The device, as modified, will be marketed under the trade name gem vr models 7227 b/d/e/cx and is indicated for use in pati |
521 Bytes |
2020-03-03 |
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11 |
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0 |
-
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| DevicePMAs@therightstef |
P980016_S039 |
Approval for the model 2490e carelink monitor and model 2491 ddma software to allow their use with the maximo dr/vr, models 7278 & 7232 and insync ii marquis, model 7289 devices. The carelink system |
374 Bytes |
2020-03-03 |
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11 |
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0 |
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| DevicePMAs@therightstef |
P920015_S024 |
Approval for the medtronic sprint quattro secure model 6947 lead. The device is indicated for single long-term use in the right ventricle. This lead has application for patients in which arrhythmia |
233 Bytes |
2020-03-03 |
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11 |
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0 |
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| DevicePMAs@therightstef |
P910077_S026 |
Approva for a switchable ECG cable that allows the clinician to display and record ECG signals from seven different vectors (leads) without moving the ECG electrodes that are attached to the patient. |
401 Bytes |
2020-03-03 |
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10 |
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4 |
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