PMA P020026S026
- Device
- CYPHER SIROLIMUS -ELUTING CORONARY STENT (4.0 MM)
- Applicant
- Cordis Corp.
- PMA number
- P020026
- Supplement
- S026
- Product code
- NIQ
- Decision date
- 2011-02-22
- Generic name
- Coronary drug-eluting stent
- Approval order statement
- APPROVAL FOR THE 4.0MM CYPHER SIROLIMUS-ELUTING CORONARY STENT ON RAPTORRAIL (RX) DELIVERY SYSTEM. THE DEVICE, AS MODIFIED WILL BE MARKETED UNDER THE TRADE NAME 4.00MM CYPHER SIROLIMUS-ELUTING CORONARY STENT ON 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 <= 30 MM IN NATIVE CORONARY ARTERIES WITH A REFERENCE VESSEL DIAMETER OF >= 2.25 TO <= 4.0 MM.
Current openFDA PMA Record#
- Device
- CYPHER SIROLIMUS -ELUTING CORONARY STENT (4.0 MM)
- Applicant
- Cordis Corp.
- PMA number
- P020026
- Supplement
- S026
- Product code
- NIQ
- Generic name
- Coronary drug-eluting stent
- Decision date
- 2011-02-22
- Decision code
- APPR
- Date received
- 2006-07-25
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR THE 4.0MM CYPHER SIROLIMUS-ELUTING CORONARY STENT ON RAPTORRAIL (RX) DELIVERY SYSTEM. THE DEVICE, AS MODIFIED WILL BE MARKETED UNDER THE TRADE NAME 4.00MM CYPHER SIROLIMUS-ELUTING CORONARY STENT ON 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 = 2.25 TO