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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameSTRATOS LV/LV-T CRT-P; COROX OTW (-S) BP & PTW-L BP LEADS
Classification Namepulse generator, pacemaker, implantable, with cardiac resynchronization (crt-p)
ApplicantBIOTRONIK, INC.
PMA NumberP070008
Supplement NumberS016
Date Received05/28/2010
Decision Date07/30/2010
Product Code
NKE[ Registered Establishments with NKE ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track no user fee
Supplement Reason location change: sterilizer
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a manufacturing site located at sterigenics germany gmbh, wiesbaden, germany as an alternate sterilization facility. 30-day notices (135 day supplement was not required) summary of pma originals & supplements approved originals: supplements: summary of pma originals under review total under review: total active: total on hold: number greater than 180 days: summary of pma supplements under review total under review: total active: total on hold: number greater than 180 days: summary of all pma submissions received originals: supplements: summary of pma supplement pma approval/denial decision times number of approvals: number of denials: average days fr receipt to decision (total time): fda time: days mfr time: days.
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