Cordis S.M.A.R.T. CONTROL and S.M.A.R.T. Vascular Stent System

FDA Premarket Approval P120002 S018

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

To replace a supplier's winding equipment used to manufacture a component of the delivery system

DeviceCordis S.M.A.R.T. CONTROL and S.M.A.R.T. Vascular Stent System
Generic NameStent, Superficial Femoral Artery
ApplicantCORDIS CORP.
Date Received2020-09-25
Decision Date2020-10-23
PMAP120002
SupplementS018
Product CodeNIP 
Advisory CommitteeCardiovascular
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address CORDIS CORP. 6500 Paseo Padre Parkway fremont, CA 94555

Supplemental Filings

Supplement NumberDateSupplement Type
P120002Original Filing
S018 2020-09-25 30-day Notice
S017 2020-05-01 30-day Notice
S016 2019-05-24 30-day Notice
S015 2019-04-01 30-day Notice
S014 2018-12-03 30-day Notice
S013 2018-02-26 30-day Notice
S012 2016-03-21 30-day Notice
S011 2015-10-05 30-day Notice
S010 2015-05-01 30-day Notice
S009 2015-03-19 135 Review Track For 30-day Notice
S008 2015-03-18 30-day Notice
S007 2015-03-11 Normal 180 Day Track No User Fee
S006 2014-12-19 Normal 180 Day Track No User Fee
S005 2014-09-23 30-day Notice
S004 2014-05-12 30-day Notice
S003 2014-04-16 30-day Notice
S002
S001 2014-03-24 30-day Notice

NIH GUDID Devices

Device IDPMASupp
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20705032063408 P120002 004

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