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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.
 
DeviceREOCOR S / D FAMILY OF EXTERNAL PACEMAKERS
Generic NamePulse Generator, External Pacemaker, Dual Chamber
Regulation Number870.3600
ApplicantBIOTRONIK, INC.
6024 Jean Road
Lake Oswego, OR 97035
PMA NumberP950037
Supplement NumberS084
Date Received07/14/2010
Decision Date05/08/2012
Product Code OVJ 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Review MemoReview 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 OrderApproval Order
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