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Device | STRATOS LV CRT-P AND STRATOS LV-T CRT-P, COROX OTW BP LEAD AND COROX OTW-S BP LEAD |
Generic Name | Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P) |
Applicant | BIOTRONIK, INC. 6024 Jean Road Lake Oswego, OR 97035 |
PMA Number | P070008 |
Date Received | 03/12/2007 |
Decision Date | 05/12/2008 |
Product Code |
NKE |
Docket Number | 08M-0335 |
Notice Date | 06/05/2008 |
Advisory Committee |
Cardiovascular |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement APPROVAL FOR THE STRATOS LV CRT-P AND STRATOS LV-T CRT-P WITH 702.U PROGRAMMER SOFTWARE FOR THE ICS 3000 AND COROX OTW BP LEAD AND COROX OTW-S BP LEAD. THE STRATOS LV CRT-P AND THE STRATOS LV-T CRT-P ARE INDICATED FOR PATIENTS WHO HAVE MODERATE TO SEVERE HEART FAILURE (NYHA CLASS II1/IV), INCLUDING LEFT VENTRICULAR DYSFUNCTION (EF< 35%) AND QRS > 120 MS AND REMAIN SYMPTOMATIC DESPITE STABLE, OPTIMAL HEART FAILURE DRUG THERAPY. THE COROX OTW BP AND COROX OTW-S BP LEFT VENTRICULAR PACING LEADS ARE BIPOLAR STEROID-ELUTING LEADS, INTENDED FOR PERMANENT IMPLANTATION IN THE LEFT VENTRICLE VIA THE CORONARY VEINS TO PROVIDE PACING AND/OR SENSING WHEN USED IN CONJUNCTION WITH A COMPATIBLE IS-1 PULSE GENERATOR. |
Approval Order | Approval Order |
Summary | Summary of Safety and Effectiveness |
Labeling | Labeling
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Post-Approval Study | Show Report Schedule and Study Progress |
Supplements: |
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