EluNIR Ridaforolimus Eluting Coronary Stent System

FDA Premarket Approval P170008 S028

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

Changes to the sampling plan for the mechanical and packaging release testing

DeviceEluNIR Ridaforolimus Eluting Coronary Stent System
Generic NameCoronary Drug-eluting Stent
ApplicantMedinol, Ltd.
Date Received2020-07-23
Decision Date2020-08-20
PMAP170008
SupplementS028
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
S028 2020-07-23 30-day Notice
S027
S026
S025 2020-03-12 30-day Notice
S024
S023
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

Device IDPMASupp
07290107013529 P170008 000
07290107013635 P170008 000
07290107013642 P170008 000
07290107013659 P170008 000
07290107013666 P170008 000
07290107013697 P170008 000
07290107013703 P170008 000
07290107013710 P170008 000
07290107013727 P170008 000
07290107013628 P170008 000
07290107013611 P170008 000
07290107013536 P170008 000
07290107013543 P170008 000
07290107013550 P170008 000
07290107013567 P170008 000
07290107013574 P170008 000
07290107013581 P170008 000
07290107013598 P170008 000
07290107013604 P170008 000
07290107013734 P170008 000
07290107013741 P170008 000
07290107013895 P170008 000
07290107013901 P170008 000
07290107013918 P170008 000
07290107013925 P170008 000
07290107013949 P170008 000
07290107013963 P170008 000
07290107013970 P170008 000
07290107013994 P170008 000
07290107013888 P170008 000
07290107013871 P170008 000
07290107013864 P170008 000
07290107013758 P170008 000
07290107013765 P170008 000
07290107013796 P170008 000
07290107013819 P170008 000
07290107013826 P170008 000
07290107013833 P170008 000
07290107013840 P170008 000
07290107013857 P170008 000
07290107013987 P170008 019
07290107013956 P170008 019
07290107013789 P170008 019
07290107013673 P170008 019

© 2020 FDA.report
This site is not affiliated with or endorsed by the FDA.