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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 NameEDP 30 EXTERNAL DUAL CHAMBER PACEMAKER
Classification Nameimplantable pacemaker pulse-generator
Generic Nameexternal dual-chamber pacemaker
Regulation Number870.3610
ApplicantBIOTRONIK, INC.
PMA NumberP950037
Supplement NumberS021
Date Received07/27/2001
Decision Date09/10/2001
Product Code
DXY[ Registered Establishments with DXY ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the external dual-chamber pacemaker models edp 30. The device, as modified, will be marketed under the trade name edp 30 and is indicated for: 1) temporary treatment of arrhythmias and heart block; 2) pre-, intra-, and postoperative temporary stimulation of patients undergoing cardiac surgery; 3) prophylactic pacing for prevention of arrhythmias, and 4) emergency pacing.
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