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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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DeviceRITHRON-XR CORONARY STENT SYSTEM
Generic NameSTENT, CORONARY
ApplicantBIOTRONIK GMBH & CO. KG
WOERMANNKEHRE 1
BERLIN D-123-1235
PMA NumberP030037
Date Received09/02/2003
Decision Date04/29/2005
Withdrawal Date 10/30/2017
Product Code MAF 
Docket Number 05M-0193
Notice Date 05/18/2005
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR THE RITHRON-XR CORONARY STENT SYSTEM. THE DEVICE IS INDICATED FOR USE IN PATIENTS ELIGIBLE FOR BALLOON ANGIOPLASTY WITH SYMPTOMATIC ISCHEMIC HEART DISEASE CHARACTERIZED BY DISCRETE DE NOVO CORONARY ARTERY LESIONS WITH REFERENCE VESSEL DIAMETER FROM >=3.0 MM OR <=4.0 MM AND TARGET LESION LENGTH <=20.0 MM.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Labeling Part 2
Supplements:  
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