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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 FAMILY OF EXTERNAL PACEMAKERS
Classification Namepulse generator, external pacemaker, dual-chamber
Generic Nameimplantable pacemaker pulse generator,pacemaker programmer
Regulation Number870.3600
ApplicantBIOTRONIK, INC.
PMA NumberP950037
Supplement NumberS084
Date Received07/15/2010
Decision Date05/08/2012
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 two new families of temporary external pacemaker pulse generators. New features include: 1) redel pacing wire connection adapters; 2) trigger modes vt and sst; 3) sensitivity settings up to 20 mv for the reocor s model; and 3) programmable av delay up to 400 ms. The device, as modified will be marketed under the trade names reocor s and reocor d and is indicated for: temporary pacing; temporary treatment of arrhythmias and heart block; symptomatic sinus bradycardia; pre-, intra-, and postoperative temporary stimulation of patients undergoing cardiac surgery; termination of supraventricular tachyarrhythmias; prophylactic pacing for prevention of arrhythmias; emergency pacing; and checking pacing thresholds.
Approval Order Approval Order
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