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
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07290107013987 P170008 019
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07290107013673 P170008 019

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