| Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling. |
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| Device | NIRFLEX PREMOUNTED STENT |
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| Generic Name | STENT, CORONARY |
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| Applicant | MEDINOL LTD.
KIRYAT ATIDIM, BLDG. 8
POB 58165
TEL-AVIV 61581 |
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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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|
Withdrawal Date
|
05/30/2014 |
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| Product Code |
MAF |
| 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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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 |
|---|
| Summary | Summary of Safety and Effectiveness |
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| Labeling | Labeling
Labeling Part 2 |
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| Supplements: |
S001 S002 S003 S004 S005 S006 S007 |
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