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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/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceCYPHER SIROLIMUS-ELUTING CORONARY STENT ON THE RAPTOR OVER-THE-WIRE DELIVERY SYSTEM OR RAPTORRAIL RAPID EXCHANGE DELIVER
Generic NameCoronary drug-eluting stent
ApplicantCORDIS CORP.
6500 Paseo Padre Parkway
Fremont, CA 94555
PMA NumberP020026
Date Received06/28/2002
Decision Date04/24/2003
Withdrawal Date 08/28/2020
Product Code NIQ 
Docket Number 03M-0172
Notice Date 09/08/2004
Advisory Committee Cardiovascular
Expedited Review Granted? Yes
Combination ProductYes
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 OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Labeling Part 2
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 S086 
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