OVATIO DR MODEL 6550 AND OVATIO VR MODEL 6250 ICDS, ELAVIEW 1.32 UG2 PROGRAMMING SOFTWARE AND CPR3 PROGRAMMING HEAD
FDA premarket approval P980049/S020 · decided 2006-04-28
Approval details
- PMA number
- P980049
- Supplement
- S020
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- OVATIO DR MODEL 6550 AND OVATIO VR MODEL 6250 ICDS, ELAVIEW 1.32 UG2 PROGRAMMING SOFTWARE AND CPR3 PROGRAMMING HEAD
- Generic name
- DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
- Applicant
- MicroPort CRM USA, Inc.
- Date received
- 2005-04-29
- Decision date
- 2006-04-28
- Days to decision
- 364 days
- Decision code
- APPR
- Product code
- MRM
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Arlington, TN
- 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
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