SUPERA PERIPHERAL STENT SYSTEM

Stent, Superficial Femoral Artery

FDA Premarket Approval P120020

This medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original pma or panel track supplement and may not represent the most recent labeling.

Pre-market Approval Supplement Details

Approval for the supera® peripheral stent system. This device is indicated to improve luminal diameter in the treatment of patients with symptomatic de novo or restenotic native lesions or occlusions of the superficial femoral artery (sfa) and/or proximal popliteal artery, with reference vessel diameters of 4. 0 to 6. 5 mm, and lesion lengths up to 140 mm.

DeviceSUPERA PERIPHERAL STENT SYSTEM
Classification NameStent, Superficial Femoral Artery
Generic NameStent, Superficial Femoral Artery
ApplicantABBOTT VASCULAR (IDEF TECHNOLOGIES INC)
Date Received2012-11-16
Decision Date2014-03-28
Notice Date2014-04-21
PMAP120020
SupplementS
Product CodeNIP
Docket Number14M-0434
Advisory CommitteeCardiovascular
Expedited ReviewNo
Combination Product No
Applicant Address ABBOTT VASCULAR (IDEF TECHNOLOGIES INC) 3200 Lakeside Drive santa Clara, CA 95054
Summary:Summary of Safety and Effectiveness
Labeling: Labeling
Post-Approval Study:Show Report Schedule and Study Progress
Approval Order: Approval Order

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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