MISAGO RX Self-expanding Peripheral Stent

Stent, Superficial Femoral Artery

FDA Premarket Approval P140002 S019

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

Approval for modifications to the sterilization cycle parameters, loading configuration, and requirements for product release from the sterilization process.

DeviceMISAGO RX Self-expanding Peripheral Stent
Classification NameStent, Superficial Femoral Artery
Generic NameStent, Superficial Femoral Artery
ApplicantTERUMO MEDICAL CORPORATION
Date Received2018-12-19
Decision Date2019-07-26
PMAP140002
SupplementS019
Product CodeNIP
Advisory CommitteeCardiovascular
Supplement Type135 Review Track For 30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address TERUMO MEDICAL CORPORATION 950 Elkton Blvd elkton, MD 21921

Supplemental Filings

Supplement NumberDateSupplement Type
P140002Original Filing
S023 2022-10-26 30-day Notice
S022 2022-09-21 30-day Notice
S021 2021-05-10 30-day Notice
S020 2019-11-06 30-day Notice
S019 2018-12-19 135 Review Track For 30-day Notice
S018 2018-10-12 30-day Notice
S017 2018-08-27 30-day Notice
S016 2018-05-04 30-day Notice
S015
S014 2018-04-19 135 Review Track For 30-day Notice
S013 2018-04-18 135 Review Track For 30-day Notice
S012 2018-04-04 30-day Notice
S011 2018-04-02 135 Review Track For 30-day Notice
S010
S009 2017-09-14 135 Review Track For 30-day Notice
S008 2017-09-14 30-day Notice
S007 2016-12-06 30-day Notice
S006 2016-09-21 135 Review Track For 30-day Notice
S005 2016-09-21 30-day Notice
S004 2016-09-19 30-day Notice
S003 2016-09-19 30-day Notice
S002 2016-05-06 Normal 180 Day Track
S001 2015-05-26 30-day Notice

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