ALTO ICD MODELS 614 AND 615
FDA premarket approval P980049/S006 · decided 2001-12-21
Approval details
- PMA number
- P980049
- Supplement
- S006
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- ALTO ICD MODELS 614 AND 615
- Generic name
- DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
- Applicant
- MicroPort CRM USA, Inc.
- Date received
- 2001-11-28
- Decision date
- 2001-12-21
- Days to decision
- 23 days
- Decision code
- APPR
- Product code
- MRM
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Arlington, TN
- Statement
- APPROVAL FOR ALTO ICD MODELS 614 AND 615. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ALTO DR MODEL 614 ICD AND ALTO VR MODEL 615, AND 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 CARDIAC ARREST (MANIFESTED BY LOSS OF CONSCIOUSNESS) DUE TO A VENTRICULAR TACHYARRHYTHMIA; 2) RECURRENT, POORLY TOLERATED, SUSTAINED VENTRICULAR TACHYCARDIA
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