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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceEDP 30 EXTERNAL DUAL CHAMBER PACEMAKER
Generic Namepermanent pacemaker Electrode
ApplicantBIOTRONIK, INC.
6024 Jean Road
Lake Oswego, OR 97035
PMA NumberP950037
Supplement NumberS021
Date Received07/27/2001
Decision Date09/10/2001
Product Codes DTB DXY 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
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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