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Device | ANGIOSCULPT SCORING BALLOON CATHETER |
Generic Name | Catheter, percutaneous transluminal coronary angioplasty (ptca), cutting/scoring |
Applicant | SPECTRANETICS CORP. 5055 BRANDIN COURT FREMONT, CA 94538 |
PMA Number | P050018 |
Date Received | 05/11/2005 |
Decision Date | 01/08/2007 |
Product Code |
NWX |
Docket Number | 07M-0032 |
Notice Date | 01/23/2007 |
Advisory Committee |
Cardiovascular |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL FOR THE ANGIOSCULPT SCORING BALLOON CATHETER. THE DEVICE IS INDICATED FOR THE TREATMENT OF HEMODYNAMICALLY SIGNIFICANT CORONARY ARTERY STENOSIS, INCLUDING IN-STENT RESTENOSIS AND COMPLEX TYPE C LESIONS, FOR THE PURPOSE OF IMPROVING MYOCARDIAL PERFUSION. |
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 S010 S011 S012 S013 S014 S015 S016 S017 S018 S019 S021 S022 S024 S025 S026 S027 S028 S030 S031 S032 S033 S034 |