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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 |
P980016_S047 |
Approval for the models 2490g and 2490j carelink monitors and model 2491 ddma software for use with the insync sentry model 7297, insync ii protect model 7295, insync maximo model 7303, onyx vr model |
473 Bytes |
2020-03-03 |
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11 |
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0 |
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| DevicePMAs@therightstef |
P910073_S043 |
Approval for addition of an eptfe coating to the shock coils. The device, as modified, will be marketed under the trade name endotak reliance g/sg lead models and is indicated for providing pacing an |
335 Bytes |
2020-03-03 |
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11 |
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0 |
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| DevicePMAs@therightstef |
P950022_S024 |
Approval for addition of the riata st lead models 7000, 7001, and 7002 to the riata defibrillation lead system. The devices, as modified, will be marketed under the trade name riata st models 7000, 7 |
273 Bytes |
2020-03-03 |
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11 |
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0 |
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| DevicePMAs@therightstef |
P980016_S389 |
Approval for clarifications to the indications for use statements related to the optivol feature and other modifications to the device labeling. the devices are indicated as follows: dual chamber icd |
1.44 KB |
2020-03-03 |
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11 |
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0 |
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| DevicePMAs@therightstef |
P910023_S000 |
Approval for the Cadence Tiered Therapy Defibrillator System. This device is indicated for use in patients with a history of hemodynamically compromising ventricular tachyarrhythmias. These patients |
1012 Bytes |
2020-03-03 |
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11 |
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0 |
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| DevicePMAs@therightstef |
P950022_S017 |
Approval for the addition of a fluoroscopic marker in the helix tip and the addition of new lead lengths and minor modifications to the suture sleeve. The leads are indicated for permanent sensing an |
297 Bytes |
2020-03-03 |
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11 |
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0 |
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| DevicePMAs@therightstef |
P900061_S050 |
Approval for the general use indication for implantable cardioverter defibrillator models 7227cx, 7227b, 7227d and 7227e and are indicated to provide ventricular antitachycardia pacing and ventricular |
284 Bytes |
2020-03-03 |
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11 |
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0 |
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| DevicePMAs@therightstef |
P110042_S000 |
Approval for the subcutaneous implantable defibrillator (s-icd) system. this device is indicated to provide defibrillation therapy for the treatment of life-threatening ventricular tachyarrhythmias in |
402 Bytes |
2020-03-03 |
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11 |
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0 |
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| DevicePMAs@therightstef |
P980016_S029 |
Approval for medtronic models 7230cx, 7230b, and 7230e marquis vr single chamber implantable cardioverter defibrillator (icd) systems with model 9967 (marquis vr) application software for use with the |
885 Bytes |
2020-03-03 |
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11 |
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0 |
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| DevicePMAs@therightstef |
P950022_S014 |
Approval for new defibrillation lead systems and accessories. The devices, as modified, will be marketed under the trade name riat series 1500 (models 1570, 1571, 1580 and 1581) defibrillation lead s |
493 Bytes |
2020-03-03 |
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11 |
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0 |
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