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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.
 
DeviceVITALITY AUTOMATIC IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (AICD) SYSTEMS AND MODEL 2857 SOFTWARE, VERSION 1.6
Generic NameImplantable pulse generator, pacemaker (non-CRT)
ApplicantBOSTON SCIENTIFIC
4100 Hamline Avenue North
St. Paul, MN 55112
PMA NumberP960040
Supplement NumberS032
Date Received04/01/2003
Decision Date10/22/2003
Product Codes KRG LWP 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
Approval Order Statement  
APPROVAL TO ENABLE THE AUTOMATIC INTRINSIC RHYTHM ID ALGORITHM UPDATE FEATURE. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME VITALITY VR/DR/VITALITY+ DR AICD SYSTEMS AND THE PROGRAMMER SOFTWARE APPLICATION MODEL 2857 VERSION 1.6 AND IS INDICATED FOR USE AS FOLLOWS: THE VITALITY VR/DR/VITALITY+ DR AICE SYSTEM IS INDICATED FOR USE IN PATIENTS WHO HAVE HAD SPONTANEOUS AND/OR INDUCIBLE LIFE-THREATENING VENTRICULAR ARRHYTHMIAS AND THOSE WHO ARE AT HIGH RISK FOR DEVELOPING SUCH ARRHYTHMIAS. IN ADDITION, THIS DEVICE IS INDICATED FOR PROPHYLACTIC TREATMENT OF PATIENTS WITH A PRIOR MYOCARDIAL INFARCTION AND EF <30%.
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