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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.
 
DeviceHOME MONITORING SYSTEM
Generic Namepermanent pacemaker Electrode
ApplicantBIOTRONIK, INC.
6024 Jean Road
Lake Oswego, OR 97035
PMA NumberP950037
Supplement NumberS019
Date Received02/23/2001
Decision Date10/11/2001
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 MODIFICATIONS TO THE HARDWARE AND SOFTWARE, INCLUDING: 1) THE ADDITION OF A LOW-POWER, RADIOFREQUENCY (RF) TRANSMITTER TO THE IMPLANTABLE PULSE GENERATOR (IPG); 2) MODIFICATION OF THE IPG SOFTWARE TO PERMIT RF TRANSMISSION OF PATIENT AND DEVICE DATA FROM THE IPG; 3) THE ADDITION OF A CELL-PHONE-LIKE PATIENT DEVICE THAT RECEIVES RF DATA TRANSMITTED BY THE IPG THEN FORWARDS THE DATA TO ABIOTRONIK SERVICE CENTER VIA A CELLULAR TELEPHONE DIGITAL DATA TRANSMISSION SERVICE; AND 4) MODIFICATION OF THE PROGRAMMER SOFTWARE TO PERMIT PROGRAMMING OF THESE NEW IPG CAPABILITIES. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME HOME MONITORING SYSTEM, INCLUDING MODEL BA03 DDDR PULSE GENERATOR, MODEL RUC 200 PATIENT DEVICE, AND MODEL B-KT0.0.A PROGRAMMER SOFTWARE, AND IS INDICATED FOR PATIENTS WITH THE FOLLOWING CONDITIONS: RATE-ADAPTIVE PACING WITH THE BA03 DDDR PULSE GENERATORS IS INDICATED FOR PATIENTS EXHIBITING CHRONOTROPIC INCOMPETENCE AND WHO WOULD BENEFIT FROM INCREASED PACING RATES CONCURRENT WITH PHYSICAL ACTIVITY. GENERALLY ACCEPTED INDICATIONS FOR LONG-TERM CARDIAC PACING INCLUDE, BUT ARE NOT LIMITED TO: SICK SINUS SYNDROME (I.E. BRADYCARDIA-TACHYCARDIA SYNDROME, SINUS ARREST, SINUS BRADYCARDIA), SINO-ATRIAL (SA) BLOCK, SECOND- AND THIRD- DEGREE AV BLOCK, AND CAROTID SINUS SYNDROME. PATIENTS WHOM DEMONSTRATE HEMODYNAMIC BENEFIT THROUGH MAINTENANCE OF AV SYNCHRONY SHOULD BE CONSIDERED FOR ONE OF THE DUAL-CHAMBER OR ATRIAL PACING MODES. DUAL-CHAMBER MODES ARE SPECIFICALLY INDICTED FOR TREATMENT OF CONDUCTION DISORDERS THAT REQUIRE BOTH RESTORATION OF RATE AND AV SYNCHRONY SUCH AS AV NODAL DISEASE, DIMINISHED CARDIAC OUTPUT OR CONGESTIVE HEART FAILURE ASSOCIATED WITH CONDUCTION DISTURBANCES, AND TACHYARRHYTHMIAS THAT ARE SUPPRESSED BY CHRONIC PACING. ADDITIONAL INDICATIONS INCLUDE: NORMAL SINUS RHYTHM AND NORMAL A-V CONDUCTION IN PATIENTS WHO INTERMITTENTLY NEED VENTRICULAR PACING SUPPORT. NOTE: PATIENTS WITH KNOWN PAROXYSMAL ATRIAL...
Approval OrderApproval Order
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