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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.
 
Trade NameBESTENT 2 OVER-THE-WIRE (OTW)/RAPID EXCHANGE CORONARY STENT DELIVERY SYSTEM
Classification Namestent, coronary
Generic Namecardiovascular stent
ApplicantMEDTRONIC VASCULAR
PMA NumberP000022
Date Received05/30/2000
Decision Date10/16/2000
Withdrawal Date 12/21/2006
Product Code
MAF[ Registered Establishments with MAF ]
Docket Number 01M-0039
Notice Date 01/31/2001
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination Product No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
Approval Order Statement 
Approval for the medtronic ave bestent(tm) 2 with discrete technology(tm) over-the-wire (otw) coronary stent delivery system and the medtronic ave bestent(tm) 2 with discrete technology(tm) rapid exchange (rx) coronary stent delivery system. The devices are indicated for improving coronary luminal diameter in patients with symptomatic heart disease due to discrete de novo lesions (length <= 30 mm) in native coronary arteries with reference vessel diameters ranging from 3. 0 mm to 4. 0 mm.
Approval Order Approval Order
Supplements: S001 S002 S003 S004 S005 S006 S007 S008 
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