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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 FAMILY OF PACING SYSTEM ANALYZERS
Classification Namepulse generator, external pacemaker, dual-chamber
Generic Nameimplantable pacemaker pulse generator,pacemaker programmer
Regulation Number870.3600
ApplicantBIOTRONIK, INC.
PMA NumberP950037
Supplement NumberS088
Date Received10/07/2010
Decision Date04/20/2011
Product Code
OVJ[ Registered Establishments with OVJ ]
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: 1) new display screen; 2) alternate battery; 3) modified battery cartridge; 4) modified battery contacts; 5) new firmware; 6) updated software; 7) modified control knob; 8) modified circuit boards; and 9) technical manual and device labeling changes.
Approval Order Approval Order
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