Supera Peripheral Stent System

FDA Premarket Approval P120020 S024

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

Addition of new stent passivation equipment.

DeviceSupera Peripheral Stent System
Generic NameStent, Superficial Femoral Artery
ApplicantABBOTT VASCULAR (IDEF TECHNOLOGIES INC)
Date Received2020-09-01
Decision Date2020-09-30
PMAP120020
SupplementS024
Product CodeNIP 
Advisory CommitteeCardiovascular
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address ABBOTT VASCULAR (IDEF TECHNOLOGIES INC) 3200 Lakeside Drive santa Clara, CA 95054

Supplemental Filings

Supplement NumberDateSupplement Type
P120020Original Filing
S024 2020-09-01 30-day Notice
S023 2019-05-16 30-day Notice
S022 2019-02-08 30-day Notice
S021 2019-01-24 30-day Notice
S020 2018-09-05 30-day Notice
S019 2018-08-24 30-day Notice
S018 2017-12-20 Normal 180 Day Track
S017 2017-09-28 135 Review Track For 30-day Notice
S016 2017-06-14 30-day Notice
S015 2016-09-08 30-day Notice
S014 2016-08-30 135 Review Track For 30-day Notice
S013 2016-05-09 Normal 180 Day Track No User Fee
S012 2015-11-24 30-day Notice
S011 2015-08-10 Normal 180 Day Track No User Fee
S010 2015-05-11 30-day Notice
S009 2015-04-28 Real-time Process
S008 2015-04-13 30-day Notice
S007 2015-02-05 30-day Notice
S006 2014-08-29 Normal 180 Day Track No User Fee
S005 2014-08-05 30-day Notice
S004 2014-05-27 135 Review Track For 30-day Notice
S003 2014-05-22 Normal 180 Day Track
S002 2014-04-08 Normal 180 Day Track No User Fee
S001 2014-03-31 Normal 180 Day Track No User Fee

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