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Device | RITHRON-XR CORONARY STENT SYSTEM |
Generic Name | STENT, CORONARY |
Applicant | BIOTRONIK GMBH & CO. KG WOERMANNKEHRE 1 BERLIN D-123-1235 |
PMA Number | P030037 |
Date Received | 09/02/2003 |
Decision Date | 04/29/2005 |
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 Product | No |
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 |
Summary | Summary of Safety and Effectiveness |
Labeling | Labeling Labeling Part 2 |
Supplements: |
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