SMART CONTROL VASCULAR STENT SYSTEM

Stent, Superficial Femoral Artery

FDA Premarket Approval P120002 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

Removal of a redundant manufacturing in-process waterborne testing step used in the stent cleaning process.

DeviceSMART CONTROL VASCULAR STENT SYSTEM
Classification NameStent, Superficial Femoral Artery
Generic NameStent, Superficial Femoral Artery
ApplicantCORDIS CORP.
Date Received2015-03-18
Decision Date2015-04-16
PMAP120002
SupplementS008
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
S022 2022-11-07 30-day Notice
S021
S020 2021-09-01 Normal 180 Day Track
S019 2021-03-03 30-day Notice
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
20705032082362 P120002 000
20705032082430 P120002 000
20705032082539 P120002 000
20705032082614 P120002 000
20705032082638 P120002 000
20705032082645 P120002 000
20705032082652 P120002 000
20705032082683 P120002 000
20705032024478 P120002 000
20705032024997 P120002 000
20705032025017 P120002 000
20705032025031 P120002 000
20705032025055 P120002 000
20705032063385 P120002 004
20705032063392 P120002 004
20705032063408 P120002 004
20705032063415 P120002 004
20705032063422 P120002 004
20705032063439 P120002 004

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