PMA P020026S085

Device
CYPHER SIROLIMUS-ELUTING CORONARY STENT
Applicant
Cordis Corp.
PMA number
P020026
Supplement
S085
Product code
NIQ
Decision date
2012-01-26
Generic name
Coronary drug-eluting stent
Approval order statement
APPROVAL TO INTEGRATE THE XTEND MANUFACTURING PROCESS INTO THE CYPHER STENT MOUNTED ON THE SONIX RX DELIVERY SYSTEM.

Current openFDA PMA Record#

Device
CYPHER SIROLIMUS-ELUTING CORONARY STENT
Applicant
Cordis Corp.
PMA number
P020026
Supplement
S085
Product code
NIQ
Generic name
Coronary drug-eluting stent
Decision date
2012-01-26
Decision code
APPR
Date received
2011-05-06
Supplement type
Normal 180 Day Track
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
APPROVAL TO INTEGRATE THE XTEND MANUFACTURING PROCESS INTO THE CYPHER STENT MOUNTED ON THE SONIX RX DELIVERY SYSTEM.