MISAGO® RX Self-expanding Peripheral Stent

FDA Premarket Approval P140002 S023

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

DeviceMISAGO® RX Self-expanding Peripheral Stent
Generic NameStent, Superficial Femoral Artery
ApplicantTERUMO MEDICAL CORPORATION950 Elkton Blvdelkton, MD 21921 PMA NumberP140002 Supplement NumberS023 Date Received10/26/2022 Decision Date11/18/2022 Product Code NIP  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
Date Received2022-10-26
Decision Date2022-11-18
PMAP140002
SupplementS023
Product CodeNIP 
Advisory CommitteeCardiovascular
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination ProductNo
Applicant AddressTERUMO MEDICAL CORPORATION
950 Elkton Blvd
elkton, MD 21921 PMA NumberP140002 Supplement NumberS023 Date Received10/26/2022 Decision Date11/18/2022 Product Code NIP  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductNo Approval Order Statement  
changes To The Endotoxin Testing Reagent, Detection Equipment And Water

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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