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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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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.
Classification Namestent, coronary
Generic Namestent, coronary
kiryat atidim, bldg. 8
pob 58165
tel-aviv 61581
PMA NumberP020040
Date Received09/25/2002
Decision Date10/24/2003
Withdrawal Date 05/30/2014
Product Code
MAF[ Registered Establishments with MAF ]
Docket Number 03M-0524
Notice Date 11/13/2003
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination Product No
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
Labeling Labeling
Labeling Part 2
Supplements: S001 S002 S003 S004 S005 S006 S007