MEDTRONIC VIRTUOSO DR/VR MODELS D154A WG/D154VWC ICDS, CONCERTO - VERTUOSO V1.0 SOFTWARE -SW002, CONEXUS ACTIVATOR 27901
FDA premarket approval P980016/S062 · decided 2006-05-12
Approval details
- PMA number
- P980016
- Supplement
- S062
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- MEDTRONIC VIRTUOSO DR/VR MODELS D154A WG/D154VWC ICDS, CONCERTO - VERTUOSO V1.0 SOFTWARE -SW002, CONEXUS ACTIVATOR 27901
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2005-11-23
- Decision date
- 2006-05-12
- Days to decision
- 170 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR THE MEDTRONIC VIRTUOSO DR/VR MODELS D154A WG/D154VWC IMPLANTABLE CARDIOVERTER DEFIBRILLATORS AND THE CONCERTO - VIRTUOSO V 1.0 SOFTWARE APPLICATION MODEL SW002. THE MEDTRONIC VIRTUOSO DR MODEL D154AWG DEVICE IS INDICATED AS FOLLOWS: THE DEVICE IS INDICATED TO PROVIDE VENTRICULAR ANTITACHYCARDIA PACING AND VENTRICULAR DEFIBRILLATION FOR AUTOMATED TREATMENT OF LIFE-THREATENING VENTRICULAR ARRHYTHMIAS IN PATIENTS WITH NYHA FUNCTIONAL CLASS II/III HEART FAILURE. IN ADDITION, THE DEVICE
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