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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 NameREOCOR S/D EXTERNAL PACEMAKER
Classification Namepulse generator, external pacemaker, dual-chamber
Generic Nameimplantable pacemaker pulse generator,pacemaker programmer
Regulation Number870.3600
ApplicantBIOTRONIK, INC.
PMA NumberP950037
Supplement NumberS111
Date Received08/13/2012
Decision Date09/24/2012
Product Code
OVJ[ Registered Establishments with OVJ ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a change to the low impedance alarm and other minor changes.
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