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Device | CYPHER SIROLIMUS-ELUTING CORONARY STENT ON THE RAPTOR OVER-THE-WIRE DELIVERY SYSTEM OR RAPTORRAIL RAPID EXCHANGE DELIVER |
Generic Name | Coronary drug-eluting stent |
Applicant | CORDIS CORP. 6500 Paseo Padre Parkway Fremont, CA 94555 |
PMA Number | P020026 |
Date Received | 06/28/2002 |
Decision Date | 04/24/2003 |
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 Product | Yes |
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 |
Summary | Summary of Safety and Effectiveness |
Labeling | Labeling Labeling Part 2 |
Post-Approval Study | Show 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 |