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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.
 
DeviceVENTAK VITALITY AVT AICD, MODELS A135 AND A155, MODEL 2920 PROGRAMMER WITH MODEL 2812 APPLICATION SOFTWARE VERSION 1.2
Generic NameImplantable pulse generator, pacemaker (non-CRT)
ApplicantBOSTON SCIENTIFIC
4100 Hamline Avenue North
St. Paul, MN 55112
PMA NumberP960040
Supplement NumberS035
Date Received09/11/2003
Decision Date10/06/2003
Product Codes KRG LWP 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
Approval Order Statement  
APPROVAL FOR A FAST-CHARGE VERSION OF THE DEVICE (MODEL A155) AND TO CORRECT SOFTWARE ANOMALIES (MODELS A155 AND A135). THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME VENTAK VITALITY AVT AICD SYSTEM AND IS INDICATED AS FOLLOWS: THE VITALITY AVT AICD SYSTEM IS INDICATED FOR USE IN PATIENTS WHO ARE ICD INDICATED AND WHO HAVE ATRIAL TACHYARRHYTHMIAS OR WHO ARE AT RISK OF DEVELOPING ATRIAL TACHYARRHYTHMIAS. PATIENT POPULATIONS WHO ARE INDICATED FOR A GUIDANT ICD INCLUDE THOSE WHO HAVE HAD SPONTANEOUS AND/OR INDUCIBLE LIFE-THREATENING VENTRICULAR ARRHYTHMIAS AND THOSE WHO ARE AT HIGH RISK FOR DEVELOPING SUCH ARRHYTHMIAS; OR, PATIENTS WHO MAY BENEFIT FROM PROPHYLACTIC TREATMENT DUE TO A PRIOR MYOCARDIAL INFARCTION AND AN EJECTION FRACTION <=30%.
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