EluNIR Ridaforolimus Eluting Coronary Stent System

Coronary Drug-eluting Stent

FDA Premarket Approval P170008 S022

This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.

Pre-market Approval Supplement Details

A change from a manual inspection system to a semi-autonomous system for labels

DeviceEluNIR Ridaforolimus Eluting Coronary Stent System
Classification NameCoronary Drug-eluting Stent
Generic NameCoronary Drug-eluting Stent
ApplicantMedinol, Ltd.
Date Received2019-10-25
Decision Date2019-11-07
PMAP170008
SupplementS022
Product CodeNIQ
Advisory CommitteeCardiovascular
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product Yes
Applicant Address Medinol, Ltd. kiryat Atidim, Bldg. 8 pob 58165 tel Aviv 61581

Supplemental Filings

Supplement NumberDateSupplement Type
P170008Original Filing
S022 2019-10-25 30-day Notice
S021 2019-08-22 30-day Notice
S020 2019-07-18 30-day Notice
S019
S018 2019-06-19 30-day Notice
S017
S016 2019-04-15 30-day Notice
S015 2019-03-15 30-day Notice
S014
S013 2019-01-24 30-day Notice
S012 2019-01-17 30-day Notice
S011 2018-10-31 135 Review Track For 30-day Notice
S010 2018-10-19 30-day Notice
S009
S008 2018-06-21 135 Review Track For 30-day Notice
S007 2018-06-20 30-day Notice
S006 2018-06-20 30-day Notice
S005 2018-05-25 30-day Notice
S004 2018-03-15 Normal 180 Day Track No User Fee
S003 2018-03-08 30-day Notice
S002 2018-02-21 135 Review Track For 30-day Notice
S001 2018-01-29 30-day Notice

NIH GUDID Devices

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