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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Trade NameRITHRON-XR CORONARY STENT SYSTEM
Classification Namestent, coronary
Generic Name coronary stent
ApplicantBIOTRONIK GMBH & CO. KG
PMA NumberP030037
Date Received09/02/2003
Decision Date04/29/2005
Product Code
MAF[ Registered Establishments with MAF ]
Docket Number 05M-0193
Notice Date 05/18/2005
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination Product No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
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 Order Approval Order
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