PMA P020026S083

Device: CYPHER SIROLIMUS CORONARY STENT ON RAPTOR OTW DELIVERY SYSTEM OR RAPTORRAIL RAPID EXCHANGE DELIVERY SYSTEM (CYPHER STENT
Applicant: Cordis Corp.
PMA number: P020026
Supplement: S083
Product code: NIQ
Decision date: 2011-05-27
Generic name: Coronary drug-eluting stent
Approval order statement: APPROVAL FOR UPDATED MAGNETIC RESONANCE IMAGING (MRI) COMPATIBILITY TESTING AND MRI CONDITIONS OF USE LABELING.

Current openFDA PMA Record#

Device: CYPHER SIROLIMUS CORONARY STENT ON RAPTOR OTW DELIVERY SYSTEM OR RAPTORRAIL RAPID EXCHANGE DELIVERY SYSTEM (CYPHER STENT
Applicant: Cordis Corp.
PMA number: P020026
Supplement: S083
Product code: NIQ
Generic name: Coronary drug-eluting stent
Decision date: 2011-05-27
Decision code: APPR
Date received: 2011-03-21
Supplement type: Real-Time Process
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: APPROVAL FOR UPDATED MAGNETIC RESONANCE IMAGING (MRI) COMPATIBILITY TESTING AND MRI CONDITIONS OF USE LABELING.