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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.
Classification Namestent, coronary
Generic Namestent, coronary
Medtronic Vascular
3576 unocal place
santa rosa, CA 95403
PMA NumberP000022
Supplement NumberS001
Date Received11/06/2000
Decision Date12/14/2000
Product Code
MAF[ Registered Establishments with MAF ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a change in the labeling to the bestent(tm) 2 with discrete technology(tm) rapid exchange (rx) coronary stent delivery system. The device is now indicated for improving coronary luminal diameter in patients with synptomatic ischenic 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. Long term outcome for this implant is unknown at present. The rapid exchange delivery system will allow for perfusion at an average rate of 2cc/min at nominal pressure during the 15-30 second stent deployment procedure only. The rapid exchange stent delivery system is not intended for use as a stand alone ptca perfusion catheter.