NIRxcell CoCr Coronary Stent on RX System

Stent, Coronary

FDA Premarket Approval P110004 S034

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

DeviceNIRxcell CoCr Coronary Stent on RX System
Classification NameStent, Coronary
Generic NameStent, Coronary
ApplicantMEDINOL LTD.
Date Received2019-10-25
Decision Date2019-11-07
PMAP110004
SupplementS034
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
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
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
07290107010870 P110004 001
07290107010863 P110004 001
07290107010856 P110004 001
07290107010849 P110004 001
07290107010832 P110004 001
07290107010825 P110004 001
07290107010818 P110004 001
07290107010801 P110004 001
07290107010795 P110004 001
07290107010788 P110004 001
07290107010771 P110004 001
07290107010764 P110004 001
07290107010924 P110004 001
07290107010931 P110004 001
07290107010948 P110004 001
07290107011068 P110004 001
07290107011051 P110004 001
07290107011044 P110004 001
07290107011037 P110004 001
07290107011020 P110004 001
07290107011013 P110004 001
07290107011006 P110004 001
07290107010955 P110004 001
07290107010962 P110004 001
07290107010979 P110004 001
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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