NIRxcell CoCr Coronary Stent on RX System

Stent, Coronary

FDA Premarket Approval P110004 S029

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

Updates to quality control testing of the d-catheter delivery system.

DeviceNIRxcell CoCr Coronary Stent on RX System
Classification NameStent, Coronary
Generic NameStent, Coronary
ApplicantMEDINOL LTD.
Date Received2018-03-08
Decision Date2018-04-05
PMAP110004
SupplementS029
Product CodeMAF
Advisory CommitteeCardiovascular
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address MEDINOL LTD. kiryat Atidim, Bldg. 7 entrance A, P.o.b. 58165 tel-aviv 61581

Supplemental Filings

Supplement NumberDateSupplement Type
P110004Original Filing
S035 2020-03-12 30-day Notice
S034 2019-10-25 30-day Notice
S033 2019-06-19 30-day Notice
S032 2019-03-15 30-day Notice
S031 2018-10-19 30-day Notice
S030 2018-05-25 30-day Notice
S029 2018-03-08 30-day Notice
S028 2018-02-21 135 Review Track For 30-day Notice
S027 2017-12-14 135 Review Track For 30-day Notice
S026 2017-11-20 30-day Notice
S025 2017-08-04 30-day Notice
S024 2017-07-17 Normal 180 Day Track No User Fee
S023 2017-06-07 Normal 180 Day Track No User Fee
S022 2017-05-08 Special (immediate Track)
S021 2016-12-05 Normal 180 Day Track No User Fee
S020 2016-07-26 30-day Notice
S019 2016-07-26 30-day Notice
S018 2016-07-21 Normal 180 Day Track
S017 2016-04-26 Normal 180 Day Track No User Fee
S016 2016-02-04 135 Review Track For 30-day Notice
S015 2015-12-11 Normal 180 Day Track No User Fee
S014 2015-09-04 30-day Notice
S013 2015-09-04 30-day Notice
S012 2015-08-07 30-day Notice
S011 2015-02-19 Special (immediate Track)
S010 2014-11-13 Normal 180 Day Track No User Fee
S009
S008
S007
S006 2014-05-05 30-day Notice
S005 2014-05-05 135 Review Track For 30-day Notice
S004 2014-05-05 30-day Notice
S003 2014-04-14 30-day Notice
S002 2014-02-14 Real-time Process
S001 2013-02-22 Normal 180 Day Track

NIH GUDID Devices

Device IDPMASupp
07290107010757 P110004 001
07290107010917 P110004 001
07290107010900 P110004 001
07290107010894 P110004 001
07290107010887 P110004 001
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07290107010863 P110004 001
07290107010856 P110004 001
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07290107011044 P110004 001
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07290107010986 P110004 001
07290107010993 P110004 001
07290107012942 P110004 018
07290107012959 P110004 018
07290107012966 P110004 018
07290107012973 P110004 018
07290107012980 P110004 018

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