| Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device. |
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| Trade Name | NIRFLEX PREMOUNTED STENT |
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| Classification Name | stent, coronary |
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| Applicant | MEDINOL LTD. |
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| PMA Number | P020040 |
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| Date Received | 09/25/2002 |
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| Decision Date | 10/24/2003 |
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| Product Code | |
| Docket Number | 03M-0524 |
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| Notice Date | 11/13/2003 |
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| Advisory Committee |
Cardiovascular |
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| Expedited Review Granted? | No |
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| Combination Product |
No
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| Information About: |
Labeling, Approval Order, Summary of Safety and Effectiveness |
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Approval Order Statement
Approval for the nirflex pre-mounted coronary stent system. The device is indicated for improving coronary luminal diameter in patients with symptomatic ischemic disease due to discrete de novo and restenotic lesions in native coronary arteries (length <= 25 mm) with a reference vessel diameter from 2. 5 mm to 4. 0 mm. |
| Approval Order |
Approval Order
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| Supplements: |
S001 S002 S003 S004 S005 S006
S007 |
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