PMA P170008S019

Device: EluNIR Ridaforolimus Eluting Coronary Stent System
Applicant: Medinol, Ltd.
Product code: NIQ
Decision date: 2019-11-19
Generic name: Coronary drug-eluting stent
Approval order statement: Approval for the expansion of the EluNIR Ridaforolimus Eluting Coronary Stent System product matrix by adding stent length of 38 mm in diameters 2.75, 3.0, 3.5 and 4.0 mm. This device is indicated for improving coronary luminal diameter in patients with symptomatic heart disease due to de novo lesions <=36mm in length in native coronary arteries with reference diameter of 2.50mm to 4.25mm.

Current openFDA PMA Record#

Device: EluNIR Ridaforolimus Eluting Coronary Stent System
Applicant: Medinol, Ltd.
PMA number: P170008
Supplement: S019
Product code: NIQ
Generic name: Coronary drug-eluting stent
Decision date: 2019-11-19
Decision code: APPR
Date received: 2019-07-10
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Approval for the expansion of the EluNIR Ridaforolimus Eluting Coronary Stent System product matrix by adding stent length of 38 mm in diameters 2.75, 3.0, 3.5 and 4.0 mm. This device is indicated for improving coronary luminal diameter in patients with symptomatic heart disease due to de novo lesions