| Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device. |
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| Trade Name | OVATIO DR MODEL 6550 AND OVATIO VR MODEL 6250 ICDS, ELAVIEW 1.32 UG2 PROGRAMMING SOFTWARE AND CPR3 PROGRAMMING HEAD |
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| Classification Name | defibrillator, implantable, dual-chamber |
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| Generic Name | implantable cardioverter-defibrillator with active housing |
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| Applicant | ELA MEDICAL, INC. |
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| PMA Number | P980049 |
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| Supplement Number | S020 |
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| Date Received | 04/29/2005 |
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| Decision Date | 04/28/2006 |
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| Product Code | |
| Advisory Committee |
Cardiovascular |
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| Supplement Type | normal 180 day track |
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| Supplement Reason | change design/components/specifications - component |
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| Expedited Review Granted? | No |
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| Combination Product |
No
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Approval Order Statement
Approval for an implantable cardioverter defibrillator (icd) that combines features of the alto 2 dr 624, alto 2 vr 625 icds, and symphony 2550 pacemaker, including reduced size, modified shock circuitry and other changes. The device will be marketed under the trade name ovatio dr model 6550 and ovatio vr model 6250 icds, elaview 1. 32 ug2 programming software and cpr3 programming head with hso 2. 76 software and is indicated for use in patients who are at high risk of sudden cardiac death due to ventricular tachyarrhythmias and who have experienced one of the following situations: 1) survival of at least one episode of cardiac arrest (manifested by the loss of consciousness) due to ventricular tachyarrhythmia, 2) recurrent, poorly tolerated sustained ventricular tachycardia (vt). Note: the clinical outcome for hemodynamically stable vt patients is not fully known. Safety and effectiveness studies have not been conducted. |
| Post-Approval Study | Show Report Schedule and Study Progress |
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