CONCERTO MODELS C154DWK / C164AWK CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATORS
FDA premarket approval P010031/S064 · decided 2007-05-04
Approval details
- PMA number
- P010031
- Supplement
- S064
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- CONCERTO MODELS C154DWK / C164AWK CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATORS
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2007-02-28
- Decision date
- 2007-05-04
- Days to decision
- 65 days
- Decision code
- APPR
- Product code
- NIK
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR UPDATES TO THE CARELINK V1.1 DEVICE DATA MANAGEMENT APPLICATION TO (1) PROVIDE SUPPORT FOR CONCERTO WITH ATRIAL THERAPIES; (2) ALLOW TRANSMISSION OF AN ?ALERT? SIGNAL FOR AT/AF BURDEN AND FAST V RESPONSE OBSERVATIONS IF THERE IS AN ASSOCIATED ALERT; (3) OUTPUT THE TYPE OF EPISODE LOG FOR INVALID EPISODES SO CARELINK CAN PROPERLY DISPLAY INVALID EPISODES AS ARRHYTHMIA EPISODES OR VENTRICULAR SENSING EPISODES; AND (4) CORRECT A PROBLEM WHERE THE CARDIAC COMPASS ?VENTRICULAR RATE DURIN
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