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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 NameMODELS S7, S670 AND S660 DISCRETE TECHNOLOGY OVER-THE-WIRE
Classification Namestent, coronary
Generic Namecardiovascular stent
ApplicantMEDTRONIC AVE, INC.
PMA NumberP970035
Supplement NumberS040
Date Received06/28/2002
Decision Date07/24/2002
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 
Change in the manufacturing process of applying the marker bands on the proximal tubing.
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