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Device | DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM |
Generic Name | CATHETER, CORONARY, ATHERECTOMY |
Applicant | CARDIOVASCULAR SYSTEMS, INC. 651 CAMPUS DR MINNEAPOLIS, MN 55211 |
PMA Number | P130005 |
Date Received | 03/15/2013 |
Decision Date | 10/21/2013 |
Product Code |
MCX |
Docket Number | 13M-1363 |
Notice Date | 10/30/2013 |
Advisory Committee |
Cardiovascular |
Clinical Trials | NCT01092416
|
Expedited Review Granted? | No |
Combination Product | Yes |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL FOR THE DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM (OAS). THE DEVICE IS INDICATED TO FACILITATE STENT DELIVERY IN PATIENTS WITH CORONARY ARTERY DISEASE (CAD) WHO ARE ACCEPTABLE CANDIDATES FOR PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) OR STENTING DUE TO DE NOVO, SEVERELY CALCIFIED CORONARY ARTERY LESIONS. |
Approval Order | Approval Order |
Summary | Summary of Safety and Effectiveness |
Labeling | Labeling
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Supplements: |
S001 S002 S003 S004 S005 S006 S007 S008 S009 S010 S011 S012 S013 S014 S015 S016 S017 S018 S019 S020 S021 S022 S024 S025 S027 S028 S029 S030 S031 S032 S033 S034 S035 S036 S037 S038 S039 S040 S041 S042 |