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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 NameRELIATY/MODEL 3145 PACING SYSTEM ANALYZER
Classification Namepulse generator, permanent, implantable
Generic Nameimplantable pacemaker pulse generator,pacemaker programmer
ApplicantBIOTRONIK, INC.
PMA NumberP950037
Supplement NumberS079
Date Received03/23/2010
Decision Date09/02/2010
Product Code
NVZ[ Registered Establishments with NVZ ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Review Memo Review Memo
Approval Order Statement 
Approval for a stand-alone version of the pacing system analyzer function found in the ics 3000 implant control system. The device, as modified, will be marketed under the trade name reliaty by biotronik, inc. And model 3145 by boston scientific and is indicated for use in pacing lead system analysis during the implantation of pacemakers and defibrillators.
Approval Order Approval Order
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