PMA P020026S069

Device
CYPHER SIROLIMUS-ELUTING CORONARY STENT ON RAPTOR OTW DELIVERY SYSTEM/RAPTORRAIL RAPID EXCHANGE DELIVERY SYSTEM
Applicant
Cordis Corp.
PMA number
P020026
Supplement
S069
Product code
NIQ
Decision date
2009-10-30
Generic name
Coronary drug-eluting stent
Approval order statement
ADDITION OF AN IN-PROCESS SAMPLING PLAN.

Current openFDA PMA Record#

Device
CYPHER SIROLIMUS-ELUTING CORONARY STENT ON RAPTOR OTW DELIVERY SYSTEM/RAPTORRAIL RAPID EXCHANGE DELIVERY SYSTEM
Applicant
Cordis Corp.
PMA number
P020026
Supplement
S069
Product code
NIQ
Generic name
Coronary drug-eluting stent
Decision date
2009-10-30
Decision code
OK30
Date received
2009-09-30
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
ADDITION OF AN IN-PROCESS SAMPLING PLAN.