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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 Rd.
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
Predetermined Change Control Plan AuthorizedNo
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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