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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.
 
Trade NameS670 WITH DISCRETE TECHNOLOGY OVER THE WIRE CORONARY STENT SYSTEM
Classification Namestent, coronary
Generic Namecardiovascular stent
ApplicantMEDTRONIC AVE, INC.
PMA NumberP970035
Supplement NumberS019
Date Received04/14/2000
Decision Date05/11/2000
Product Code
MAF[ Registered Establishments with MAF ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Requesting that the three-step manufacturing process of the distal and intermediate tubing be reduced to a two-step manufacturing process of the distal and intermediate tubing be reduced to a two-step process whereby the forming step will be completely removed and the tubing will be extruded to the final dimensions.
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