SUPERA PERIPHERAL STENT SYSTEM

Stent, Superficial Femoral Artery

FDA Premarket Approval P120020 S008

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

Move the endotoxin testing prior to sterilization.

DeviceSUPERA PERIPHERAL STENT SYSTEM
Classification NameStent, Superficial Femoral Artery
Generic NameStent, Superficial Femoral Artery
ApplicantABBOTT VASCULAR (IDEF TECHNOLOGIES INC)
Date Received2015-04-13
Decision Date2015-05-12
PMAP120020
SupplementS008
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
S030 2022-11-21 135 Review Track For 30-day Notice
S029 2022-09-30 Real-time Process
S028 2022-09-30 Real-time Process
S027 2021-09-08 30-day Notice
S026 2021-01-05 Normal 180 Day Track
S025 2020-11-24 30-day Notice
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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