EluNIR TM Ridaforolimus Eluting Coronary Stent System

FDA Premarket Approval P170008 S040

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

DeviceEluNIR TM Ridaforolimus Eluting Coronary Stent System
Generic NameCoronary Drug-eluting Stent
ApplicantMedinol, Ltd.kiryat Atidim, Bldg. 8pob 58165tel Aviv 61581 PMA NumberP170008 Supplement NumberS040 Date Received03/22/2022 Decision Date04/14/2022 Product Code NIQ  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
Date Received2022-03-22
Decision Date2022-04-14
PMAP170008
SupplementS040
Product CodeNIQ 
Advisory CommitteeCardiovascular
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination ProductYes
Applicant AddressMedinol, Ltd.
kiryat Atidim, Bldg. 8
pob 58165
tel Aviv 61581 PMA NumberP170008 Supplement NumberS040 Date Received03/22/2022 Decision Date04/14/2022 Product Code NIQ  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductYes Approval Order Statement  
to Establish New Cleanroom Parameters During Off Hours

Supplemental Filings

Supplement NumberDateSupplement Type
P170008Original Filing
S041 2022-03-22 30-day Notice
S040 2022-03-22 30-day Notice
S039 2022-03-22 30-day Notice
S038 2021-11-12 Normal 180 Day Track
S037
S036 2021-05-17 30-day Notice
S035 2021-03-18 30-day Notice
S034 2021-03-08 30-day Notice
S033 2021-03-01 30-day Notice
S032
S031 2020-11-23 30-day Notice
S030 2020-11-09 30-day Notice
S029 2020-10-26 30-day Notice
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
07290107014564 P170008 019
07290107014571 P170008 019
07290107014588 P170008 019
07290107014595 P170008 019
07290107013673 P170008 019
07290107013987 P170008 019
07290107013956 P170008 019
07290107013789 P170008 019
07290107015370 P170008 037
07290107015288 P170008 037
07290107015295 P170008 037
07290107015301 P170008 037
07290107015318 P170008 037
07290107015325 P170008 037
07290107015400 P170008 037
07290107015394 P170008 037
07290107015387 P170008 037
07290107015332 P170008 037
07290107015349 P170008 037
07290107015356 P170008 037
07290107015363 P170008 037
07290107015271 P170008 037
07290107015264 P170008 037
07290107015257 P170008 037
07290107017930 P170008 037
07290107017947 P170008 037
07290107017954 P170008 037
07290107017961 P170008 037
07290107017978 P170008 037
07290107017985 P170008 037
07290107017992 P170008 037
07290107018005 P170008 037
07290107015202 P170008 037
07290107015219 P170008 037
07290107015226 P170008 037
07290107015233 P170008 037
07290107015240 P170008 037
07290107015417 P170008 037
07290107015424 P170008 037
07290107015554 P170008 037
07290107015561 P170008 037
07290107015578 P170008 037
07290107015585 P170008 037
07290107015608 P170008 037
07290107015615 P170008 037
07290107015622 P170008 037
07290107015639 P170008 037
07290107015592 P170008 037
07290107015547 P170008 037
07290107015530 P170008 037
07290107015523 P170008 037
07290107015431 P170008 037
07290107015448 P170008 037
07290107015455 P170008 037
07290107015462 P170008 037
07290107015479 P170008 037
07290107015486 P170008 037
07290107015493 P170008 037
07290107015509 P170008 037
07290107015516 P170008 037
07290107016735 P170008 038
07290107016711 P170008 038
07290107016704 P170008 038
07290107016698 P170008 038
07290107016681 P170008 038
07290107014663 P170008 038
07290107014632 P170008 038
07290107016728 P170008 038

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.