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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 Namecoronary drug-eluting stent
Generic Namedrug eluting stent
PMA NumberP020026
Supplement NumberS026
Date Received07/26/2006
Decision Date02/22/2011
Product Code
NIQ[ Registered Establishments with NIQ ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Approval for the 4. 0mm cypher sirolimus-eluting coronary stent on raptorrail (rx) delivery system. The device, as modified will be marketed under the trade name 4. 00mm cypher sirolimus-eluting coronary stent on raptorrail rapid exchange delivery system and is indicated for improving coronary luminal diameter in patients with symptomatic ischemic disease due to discrete de novo lesions of length <= 30 mm in native coronary arteries with a reference vessel diameter of >= 2. 25 to <= 4. 0 mm.