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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
DeviceBESTENT 2 WITH DISCRETE TECHNOLOGY OTW/RAPID EXCHANGE CORONARY STENT DELIVERY SYSTEM
Classification Namestent, coronary
Generic Namestent, coronary
Applicant
Medtronic Vascular
3576 unocal place
santa rosa, CA 95403
PMA NumberP000022
Supplement NumberS002
Date Received11/16/2000
Decision Date03/15/2001
Product Code
MAF[ Registered Establishments with MAF ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason other report
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the postapproval study protocol for the bestent(tm) 2 with discrete technology(tm) rapid exchange coronary stent delivery system.
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