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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceVITUOSO DR, VIRTUOSO VR, VIRTUOSO II DR, VIRTUOSO II VR, SECURA DR, SECURA VR, PROTECTA XT DR, PROTECTA XT VR
Generic NameImplantable cardioverter defibrillator (non-CRT)
ApplicantMedtronic Cardiac Rhythm Disease Management
8200 Coral Sea St. N.E
Ms Mvs11
Mounds View, MN 55112
PMA NumberP980016
Supplement NumberS389
Date Received11/07/2012
Decision Date02/05/2013
Product Code LWS 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR CLARIFICATIONS TO THE INDICATIONS FOR USE STATEMENTS RELATED TO THE OPTIVOL FEATURE AND OTHER MODIFICATIONS TO THE DEVICE LABELING. THE DEVICES ARE INDICATED AS FOLLOWS: DUAL CHAMBER ICDSTHE DR SYSTEM IS INDICATED TO PROVIDE VENTRICULAR ANTITACHYCARDIA PACING AND VENTRICULAR DEFIBRILLATION FOR AUTOMATED TREATMENT OF LIFE-THREATENING VENTRICULAR ARRHYTHMIAS. IN ADDITION, THE DEVICE IS INDICATED FOR USE IN THE ABOVE PATIENTS WITH ATRIALTACHYARRHYTHMIAS, OR THOSE PATIENTS WHO ARE AT SIGNIFICANT RISK OF DEVELOPING ATRIAL TACHYARRHYTHMIAS. NOTES:1) THE USE OF THE DEVICE HAS NOT BEEN DEMONSTRATED TO DECREASE THE MORBIDITY RELATED TO ATRIAL TACHYARRHYTHMIAS.2) THE EFFECTIVENESS OF HIGH-FREQUENCY BURST PACING (ATRIAL 50 HZ BURST THERAPY) IN TERMINATING DEVICE CLASSIFIED ATRIAL TACHYCARDIA (AT) WAS FOUND TO BE 17%, AND IN TERMINATING DEVICE CLASSIFIED ATRIAL FIBRILLATION (AF) WAS FOUND TO BE 16.8%, IN THE VT/AT PATIENT POPULATION STUDIED. 3) THE EFFECTIVENESS OF HIGH-FREQUENCY BURST PACING (ATRIAL 50 HZ BURST THERAPY) IN TERMINATING DEVICE CLASSIFIED ATRIAL TACHYCARDIA (AT) WAS FOUND TO BE 11.7%, AND IN TERMINATING DEVICE CLASSIFIED ATRIAL FIBRILLATION (AF) WAS FOUND TO 18.2% IN THE AF-ONLY PATIENT POPULATION STUDIED.SINGLE CHAMBER ICDS: THE VR SYSTEM IS INDICATED TO PROVIDE VENTRICULAR ANTITACHYCARDIA PACING AND VENTRICULAR DEFIBRILLATION FOR AUTOMATED TREATMENT OF LIFE-THREATENING VENTRICULAR ARRHYTHMIAS.
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