PMA P020026S082

Device
CYPHER SIROLIMUS-ELUTING CORONARY STENT
Applicant
Cordis Corp.
PMA number
P020026
Supplement
S082
Product code
NIQ
Decision date
2012-01-27
Generic name
Coronary drug-eluting stent
Approval order statement
APPROVAL FOR THE SONIX RAPID EXCHANGE DELIVERY SYSTEM FOR THE CYPHER SIROLIMUS-ELUTING CORONARY STENT.

Current openFDA PMA Record#

Device
CYPHER SIROLIMUS-ELUTING CORONARY STENT
Applicant
Cordis Corp.
PMA number
P020026
Supplement
S082
Product code
NIQ
Generic name
Coronary drug-eluting stent
Decision date
2012-01-27
Decision code
APPR
Date received
2010-11-15
Supplement type
Normal 180 Day Track
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
APPROVAL FOR THE SONIX RAPID EXCHANGE DELIVERY SYSTEM FOR THE CYPHER SIROLIMUS-ELUTING CORONARY STENT.