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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.
 
DeviceSOLOX VDD PACING LEAD
Generic Namepermanent pacemaker Electrode
ApplicantBIOTRONIK, INC.
6024 Jean Road
Lake Oswego, OR 97035
PMA NumberP950037
Supplement NumberS024
Date Received12/31/2001
Decision Date04/23/2003
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 SOLOX VDD PACING LEAD. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME SOLOX VDD PACING LEAD AND IS INDICATED AS FOLLOWS: THE SOLOX LEAD IS INDICATED FOR USE AS PART OF A SYSTEM ONLY. THE SYSTEM INCLUDES ANY OF BIOTRONIK'S VDD DUAL CHAMBER PULSE GENERATORS AND THE SOLOX VDD LEAD. THEREFORE, THE INDICATIONS FOR THE SOLOX VDD LEAD ARE IDENTICAL TO THE INDICATIONS FOR USE OF BIOTRONIK'S VDD DUAL CHAMBER PULSE GENERATORS. BIOTRONIK'S VDD DUAL CHAMBER PULSE GENERATORS ARE PRIMARILY INTENDED TO PROVIDE VDD PACING FOR PATIENTS WITH A HEALTHY SINUS NODE. THESE PULSE GENERATORS ARE SPECIFICALLY INDICATED FOR PATIENTS WHO NEED VENTRICULAR PACING WHEN ADEQUATE ATRIAL RATES ARE PRESENT. THIS INCLUDES THE PRESENCE OF COMPLETE A-V BLOCK WHEN: 1) ATRIAL CONTRIBUTION IS NEEDED FOR HEMODYNAMIC BENEFIT AND 2) PACEMAKER SYNDROME HAD EXISTED OR IS ANTICIPATED. ADDITIONAL INDICATIONS INCLUDE: NORMAL SINUS RHYTHM AND NORMAL A-V CONDUCTIONS IN PATIENTS WHO INTERMITTENTLY NEED VENTRICULAR PACING SUPPORT. NOTE: PATIENTS WITH KNOWN PAROXYSMAL ATRIAL FIBRILLATION/FLUTTER MAY REQUIRE FURTHER EVALUATION PRIOR TO IMPLANTATION. OTHER PACING MODES ARE INCORPORATE DIN THE PULSE GENERATOR (VDDR, VVI, VVIR, VOO, VOOR, VDT, VVT, AND VDI) IN ORDER TO PROVIDE CLINICAL FLEXIBILITY TO MANAGE CHANGES IN THE PATIENT'S CONDITION, FOR DIAGNOSTIC PURPOSES, OR IN THE EVENT THAT VDD PACING BECOMES INAPPROPRIATE.
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