| Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device. |
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| Trade Name | STRATOS LV CRT-P AND STRATOS LV-T CRT-P, COROX OTW BP LEAD AND COROX OTW-S BP LEAD |
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| Classification Name | pulse generator, pacemaker, implantable, with cardiac resynchronization (crt-p) |
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| Applicant | BIOTRONIK, INC. |
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| PMA Number | P070008 |
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| Date Received | 03/12/2007 |
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| Decision Date | 05/12/2008 |
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| Product Code | |
| Docket Number | 08M-0335 |
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| Notice Date | 06/05/2008 |
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| Advisory Committee |
Cardiovascular |
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| Expedited Review Granted? | No |
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| Combination Product |
Yes
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| Information About: |
Labeling, Approval Order, Summary of Safety and Effectiveness |
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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
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| Post-Approval Study | Show Report Schedule and Study Progress |
| Supplements: |
S001 S002 S003 S004 S005 S006
S007 S008 S009 S010 S011 S012
S013 S014 S015 S016 S017 S018
S019 S020 S021 S023 S024 S025
S026 S027 S028 S029 S030 S031
S032 S033 S034 S035 S036 S037
S038 S039 S041 |
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