| 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. |
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| Device | VITALITY AVT AND THE PROGRAMMER SOFTWARE APPLICATION MODEL 2812 |
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| Generic Name | Implantable pulse generator, pacemaker (non-CRT) |
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| Applicant | BOSTON SCIENTIFIC
4100 Hamline Avenue North
St. Paul, MN 55112 |
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| PMA Number | P960040 |
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| Supplement Number | S029 |
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| Date Received | 09/03/2002 |
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| Decision Date | 03/26/2003 |
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| Product Codes |
KRG LWP |
| Advisory Committee |
Cardiovascular |
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| Supplement Type | Normal 180 Day Track |
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| Supplement Reason | Change Design/Components/Specifications/Material |
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| Expedited Review Granted? | No |
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| Combination Product | No |
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| Recalls | CDRH Recalls |
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Approval Order Statement
APPROVAL FOR THE ADDITION OF ATRIAL ARRHYTHMIA THERAPIES TO THE VITALITY AICD SYSTEM. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME VITALITY AVT AND PROGRAMMER SOFTWARE APPLICATION MODEL 2812, AND IS INDICATED FOR USE IN THE FOLLOWING: 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: 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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