PMA P020026S078

Device: CYPHER SIROLIMUS-ELUTING CORONARY STENT ON RAPTOR OTW DELIVERY SYSTEM/RAPTORRAIL RAPID EXCHANGE DELIVERY SYSTEM
Applicant: Cordis Corp.
PMA number: P020026
Supplement: S078
Product code: NIQ
Decision date: 2010-09-02
Generic name: Coronary drug-eluting stent
Approval order statement: APPROVAL FOR A CHANGE IN SAMPLING PLAN FROM LOT-TO-LOT TO A SKIP-LOT TESTING 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: S078
Product code: NIQ
Generic name: Coronary drug-eluting stent
Decision date: 2010-09-02
Decision code: APPR
Date received: 2010-01-11
Supplement type: 135 Review Track For 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: APPROVAL FOR A CHANGE IN SAMPLING PLAN FROM LOT-TO-LOT TO A SKIP-LOT TESTING PLAN.