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Device | VENTAK PRIZM 2 VR/DR MODELS 1860/1861, VENTAK PRIZM VR/DR MODELS 1850/1851/1855/ |
Generic Name | Implantable cardioverter defibrillator (non-CRT) |
Applicant | BOSTON SCIENTIFIC 4100 Hamline Avenue North St. Paul, MN 55112 |
PMA Number | P910077 |
Supplement Number | S037 |
Date Received | 12/14/2001 |
Decision Date | 07/18/2002 |
Product Code |
LWS |
Docket Number | 02M-0352 |
Notice Date | 08/08/2002 |
Advisory Committee |
Cardiovascular |
Supplement Type | Panel Track |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | Yes |
Combination Product | No |
Approval Order Statement APPROVAL FOR THE VENTAK PRIZM 2 VR/DR MODELS 1860/1861, VENTAK PRIZM VR/DR MODELS 1850/1851/1855/1856, VENTAK PRIZM VR/DR HE MODELS 1852/1853, VENTAK MINI IV MODELS 1790/1793/1796 AND VENTAK MINI III HE MODEL 1789. THESE DEVICES ARE INDICATED 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, THESE DEVICES ARE INDICATED FOR PROPHYLACTIC TREATMENT OF PATIENTS WITH A PRIOR MYOCARDIAL INFARCTION AND AN EJECTION FRACTION (EF) <=30% (AS DEFINED IN THE CLINICAL STUDY SECTION). |
Approval Order | Approval Order |
Summary | Summary of Safety and Effectiveness |
Labeling | Labeling
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