MEDTRONIC CONCERTO MODEL C154DWK ICD
FDA premarket approval P010031/S057 · decided 2007-04-17
Approval details
- PMA number
- P010031
- Supplement
- S057
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- MEDTRONIC CONCERTO MODEL C154DWK ICD
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2006-11-07
- Decision date
- 2007-04-17
- Days to decision
- 161 days
- Decision code
- APPR
- Product code
- NIK
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR THE MEDTRONIC CONCERTO MODELS C154DWK AND C164AWK ICD SYSTEMS AND CONCERTO-VIRTUOSO V1.2 SOFTWARE APPLICATION MODEL SW002. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME MEDTRONIC CONCERTO MODELS C154DWK AND C164AWK ICD SYSTEMS AND IS INDICATED AS FOLLOW: THE CONCERTO IS INDICATED FOR VENTRICULAR ANTITACHYCARDIA PACING AND VENTRICULAR DEFIBRILLATION FOR AUTOMATED TREATMENT OF LIFE THREATENING VENTRICULAR ARRHYTHMIAS. IN ADDITION, THE DEVICE IS INDICATED FOR USE IN PA
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