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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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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.
 
Trade NameSTRATOS LV CRT-P AND STRATOS LV-T CRT-P, COROX OTW BP LEAD AND COROX OTW-S BP LEAD
Classification Namepulse generator, pacemaker, implantable, with cardiac resynchronization (crt-p)
ApplicantBIOTRONIK, INC.
PMA NumberP070008
Date Received03/12/2007
Decision Date05/12/2008
Product Code
NKE[ Registered Establishments with NKE ]
Docket Number 08M-0335
Notice Date 06/05/2008
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination Product Yes
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
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
Post-Approval StudyShow 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 S042 S043 S044 S045 S046 S047 
S048 S049 S050 S051 S052 S054 S056 
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