PMA P170008S004

Device: EluNIR™ Ridaforolimus Eluting Coronary Stent System
Applicant: Medinol, Ltd.
PMA number: P170008
Supplement: S004
Product code: NIQ
Decision date: 2018-06-07
Classification: Coronary Drug-eluting Stent
Generic name: Coronary drug-eluting stent
Approval order statement: Approval for adding a manufacturing site for a component, the D-catheter delivery system, for the EluNIR Ridaforolimus Eluting Coronary Stent System.

Current openFDA PMA Record#

Device: EluNIR™ Ridaforolimus Eluting Coronary Stent System
Applicant: Medinol, Ltd.
PMA number: P170008
Supplement: S004
Product code: NIQ
Generic name: Coronary drug-eluting stent
Decision date: 2018-06-07
Decision code: APPR
Date received: 2018-03-15
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Location Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Approval for adding a manufacturing site for a component, the D-catheter delivery system, for the EluNIR Ridaforolimus Eluting Coronary Stent System.