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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements 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
ApplicantCORDIS CORP.
PMA NumberP020026
Date Received06/28/2002
Decision Date04/24/2003
Product Code
NIQ[ Registered Establishments with NIQ ]
Docket Number 03M-0172
Notice Date 09/08/2004
Advisory Committee Cardiovascular
Expedited Review Granted? Yes
Combination Product Yes
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
Approval Order Statement 
Approval for the cypher sirolimus-eluting coronary stent on the raptor over-the-wire delivery system or raptorrail rapid exchange delivery system. The device 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. 5 to <= 3. 5 mm. Long-term outcome (beyond 12 months) for this permanent implant is unknown at present.
Approval Order Approval Order
Post-Approval StudyShow Report Schedule and Study Progress
Supplements: S001 S003 S004 S005 S008 S010 S011 S013 S014 
S015 S016 S017 S018 S021 S022 S023 S025 S026 
S028 S029 S030 S031 S032 S033 S034 S035 S036 
S037 S038 S039 S040 S041 S042 S044 S045 S046 
S047 S048 S050 S051 S052 S053 S055 S056 S057 
S058 S059 S060 S061 S063 S066 S067 S068 S069 
S070 S071 S072 S073 S074 S075 S077 S078 S079 
S080 S081 S082 S083 S085 
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