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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/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.
 
DeviceAVE MICRO STENT II OVER-THE-WIRE CORONARY STENT SYSTEM AND AVE GFX OVER-THE-WIRE CORONARY STENT SYSTEM
Generic NameSTENT, CORONARY
ApplicantMEDTRONIC IRELAND
Parkmore Business Park West
Galway 
PMA NumberP970035
Date Received08/05/1997
Decision Date12/23/1997
Withdrawal Date 10/18/2010
Product Code MAF 
Docket Number 98M-0973
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for the AVE Micro Stent(TM) II Over-the-Wire Coronary Stent System and the AVE GFX(TM) Over-the-Wire Coronary Stent System. The devices are indicated for use in patients eligible for balloon angioplasty with symptomatic ischemic disease due to discrete de novo lesions in native coronary arteries (length < 30 mm) with a reference vessel diameter of 3.0 mm to 4.0 mm. Stenting is intended to improve coronary luminal diameter (see Individualization of Treatment). Long term outcome (beyond 6 months) for this permanent implant is unknown at present.
Supplements:  S014 S015 S016 S017 S018 S024 S025 S026 S046 S047 S038 
S039 S040 S041 S042 S043 S003 S005 S006 S007 S027 S028 S029 
S030 S031 S002 S045 S035 S036 S023 S019 S020 S021 S022 S008 
S009 S010 S011 S012 S032 S033 
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