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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 NumberS017
Date Received04/03/2006
Decision Date09/18/2009
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 2. 25 mm cypher stent on raptorrail rx stent delivery system. The device, as modified, will be marketed under the trade name cypher 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 <=3. 50 mm.
Post-Approval StudyShow Report Schedule and Study Progress