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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.
 
DevicePHILOS II DR-T
Generic NamePulse generator, permanent, implantable
ApplicantBIOTRONIK, INC.
6024 Jean Road
Lake Oswego, OR 97035
PMA NumberP950037
Supplement NumberS068
Date Received01/26/2009
Decision Date05/12/2009
Product Code NVZ 
Advisory Committee Cardiovascular
Clinical TrialsNCT00336284
Supplement TypeNormal 180 Day Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR MODIFICATION OF PRODUCT LABELING FOR DEVICES THAT UTILIZE HOME MONITORING. SPECIFICALLY, SUPPLEMENTS REQUESTED APPROVAL FOR THE REPLACEMENT OF EXISTINGPRECAUTIONS AND THE FOLLOWING MARKETING STATEMENTS:1) BIOTRONIC HOME MONITORING INFORMATION MAY BE USED AS A REPLACEMENT FORDEVICE INTERROGATION DURING IN-OFFICE FOLLOW-UP VISITS.2) A STRATEGY OF CARE USING BIOTRONIK HOME MONITORING WITH OFFICE VISITS WHEN NEEDED - HAS BEEN SHOWN TO EXTEND THE LIME BETWEEN ROUTINE, SCHEDULED IN-OFFICEFOLLOW-UPS OF BIOTRONIK IMPLANTABLE DEVICES IN MANY PATIENTS. HOME MONITORING DATA IS HELPFUL IN DETERMINING THE NEED FOR ADDITIONAL IN-OFFICE FOLLOW-UP.3) BIOTRONIK HOME MONITORING PATIENTS -WHO ARE FOLLOWED REMOTELY WITH OFFICEVISITS WHEN NEEDED - HAVE BEEN SHOWN TO HAVE SIMILAR NUMBERS OF STROKES, INVASIVE PROCEDURES AND DEATHS AS PATIENTS FOLLOWED WITH CONVENTIONAL IN-OFFICE FOLLOW-UPS.4) BIOTRONIK HOME MONITORING PROVIDES EARLY DETECTION OF ARRHYTHMIAS.5) BIOTRONIK HOME MONITORING PROVIDES EARLY DETECTION OF SILENT, ASYMPTOMATIC ARRHYTHMIAS.6) AUTOMATIC EARLY DETECTION OF ARRHYTHMIAS AND DEVICE SYSTEM ANOMALIES BYBIOTRONIK HOME MONITORING ALLOWS FOR EARLIER INTERVENTION THAN CONVENTIONAL IN-OFFICEFOLLOW-UPS.7) BIOTRONIK HOME MONITORING ALLOWS FOR IMPROVED ACCESS TO PATIENT DEVICE DATA COMPARED TO CONVENTIONAL IN-OFFICE FOLLOW-UPS SINCE DEVICE INTERROGATION IS AUTOMATICALLYSCHEDULED AT REGULAR INTERVALS.
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