| Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
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| Device | OVATIO DR MODEL 6550 AND OVATIO VR MODEL 6250 ICDS, ELAVIEW 1.32 UG2 PROGRAMMING SOFTWARE AND CPR3 PROGRAMMING HEAD |
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| Generic Name | DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER |
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| Applicant | MicroPort CRM USA Inc.
5640 Airline Road
Arlington, TN 38002 |
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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 |
MRM |
| Advisory Committee |
Cardiovascular |
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| Supplement Type | Normal 180 Day Track |
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| Supplement Reason | Change Design/Components/Specifications/Material |
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| Expedited Review Granted? | No |
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| Combination Product | No |
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| Recalls | CDRH Recalls |
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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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