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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 NameCYPHER SIROLIMUS-ELUTING CORONARY STENT ON THE RAPTOR OVER-THE-WIRE DELIVERY SYSTEM OR RAPTORRAIL RAPID EXCHANGE DELIVER
Classification Namecoronary drug-eluting stent
Generic Namedrug eluting stent
ApplicantCORDIS CORPORATION
PMA NumberP020026
Supplement NumberS014
Date Received07/18/2005
Decision Date05/17/2006
Product Code
NIQ[ Registered Establishments with NIQ ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason process change - other
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Approval to implement new orthogonal methods to quantitate drug content, impurities and degradation products for the cypher stent. Based upon these new methods, you have also requested approval for new specifications for impurities and degradation products for the cypher stent at finished goods release testing and on stability. The device, as modified, will be marketed under the trade name cypher sirolimus-eluting coronary stent on the raptor over-the-wire delivery system or 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 <= 30mm in native coronary arteries with reference vessel diameter of >= 2. 5 mm to <= 3. 5 mm.
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