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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 DS ICD SYSTEMS
Generic NameImplantable pulse generator, pacemaker (non-CRT)
ApplicantBOSTON SCIENTIFIC
4100 Hamline Avenue North
St. Paul, MN 55112
PMA NumberP960040
Supplement NumberS031
Date Received03/17/2003
Decision Date07/10/2003
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 FOR THE VITALITY DS VR MODEL T135, VITALITY DS MODEL T125, AND VITALITY EL MODEL T127 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEMS AND THE PROGRAMMER SOFTWARE APPLICATION MODEL 2844 VERSION 3.6. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME VITALITY DS VR MODEL T135, VITALITY DS MODEL T125, AND VITALITY EL MODEL T127 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEMS AND THE PROGRAMMER SOFTWARE APPLICATION MODEL 2844 VERSION 3.6, AND THE INDICATION FOR USE IS AS FOLLOWS:GUIDANT ICDS ARE INTENDED TO PROVIDE THERAPY FOR THE AUTOMATED TREATMENT OF LIFE THREATENING VENTRICULAR ARRHYTHMIAS. PATIENT POPULATIONS WHO ARE INDICATED FOR A GUIDANT ICD INCLUDE 1) THOSE WHO HAVE HAD SPONTANEOUS AND/OR INDUCIBLE LIFE-THREATENING VENTRICULAR ARRHYTHMIAS AND THOSE WHO ARE AT HIGH RISK FOR DEVELOPING SUCH ARRHYTHMIAS, OR 2) PATIENTS WHO MAY BENEFIT FROM PROPHYLACTIC TREATMENT DUE TO A PRIOR MYOCARDIAL INFARCTION AND AN EJECTION FRACTION OF <=30% (AS DEFINED IN APPENDIX E ).
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