PMA P020026S059

Device: CYPHER SIROLIMUS-ELUTING CORONARY STENT ON RAPTOR OVER-THE-WIRE DELIVERY SYSTEM/RAPTORRAIL RAPID EXCHANGE DELIVERY SYSTE
Applicant: Cordis Corp.
PMA number: P020026
Supplement: S059
Product code: NIQ
Decision date: 2011-05-27
Generic name: Coronary drug-eluting stent
Approval order statement: APPROVAL FOR THE XTEND MANUFACTURING PROCESS AND AN EXTENSION OF YOUR APPROVED SHELF LIFE FROM 3 TO 6 MONTHS.

Current openFDA PMA Record#

Device: CYPHER SIROLIMUS-ELUTING CORONARY STENT ON RAPTOR OVER-THE-WIRE DELIVERY SYSTEM/RAPTORRAIL RAPID EXCHANGE DELIVERY SYSTE
Applicant: Cordis Corp.
PMA number: P020026
Supplement: S059
Product code: NIQ
Generic name: Coronary drug-eluting stent
Decision date: 2011-05-27
Decision code: APPR
Date received: 2008-12-08
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR THE XTEND MANUFACTURING PROCESS AND AN EXTENSION OF YOUR APPROVED SHELF LIFE FROM 3 TO 6 MONTHS.