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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
Classification Nameimplantable pulse generator, pacemaker (non-crt)
Generic Nameimplantable pulse generator, pacemaker (non-crt)
Applicant
BOSTON SCIENTIFIC
4100 hamline avenue north
st. paul, MN 55112
PMA NumberP960040
Supplement NumberS025
Date Received11/14/2001
Decision Date04/23/2003
Product Code
LWP[ Registered Establishments with LWP ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
APPROVAL FOR VITALITY AUTOMATIC IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (AICD) SYSTEMS (VITALITY DR MODEL 1871, VITALITY VR MODEL 1870 AND VITALITY + DR MODEL 1872), AND MODEL 2857 SOFTWARE, VERSION 1.5. THE DEVICE IS INDICATED FOR USE IN THE FOLLOWING: THE VITALITY AICD SYSTEM IS INTENDED TO PROVIDE THERAPY FOR THE AUTOMATED TREATMENT OF LIFE THREATENING VENTRICULAR ARRHYTHMIAS. PATIENT POPULATIONS WHO ARE INDICATED FOR A GUIDANT AICD 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 <= 30% (AS DEFINED IN THE MADIT II CLINICAL STUDY APPENDIX).
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