COMPLETE SE VASCULAR STENT SYSTEM- ILIAC

Stent, Iliac

FDA Premarket Approval P090006 S016

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

Changes to the manufacturing equipment used in assembly of the complete se vascular stent system.

DeviceCOMPLETE SE VASCULAR STENT SYSTEM- ILIAC
Classification NameStent, Iliac
Generic NameStent, Iliac
ApplicantMedtronic Vascular
Date Received2015-09-24
Decision Date2015-10-20
PMAP090006
SupplementS016
Product CodeNIO
Advisory CommitteeCardiovascular
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address Medtronic Vascular 3576 Unocal Place santa Rosa, CA 95403

Supplemental Filings

Supplement NumberDateSupplement Type
P090006Original Filing
S019 2016-08-17 135 Review Track For 30-day Notice
S018 2016-07-13 30-day Notice
S017 2016-05-05 30-day Notice
S016 2015-09-24 30-day Notice
S015 2015-03-20 135 Review Track For 30-day Notice
S014 2014-03-04 30-day Notice
S013 2014-01-09 30-day Notice
S012 2013-12-16 30-day Notice
S011 2013-09-16 30-day Notice
S010 2013-04-22 30-day Notice
S009 2013-03-11 135 Review Track For 30-day Notice
S008 2012-03-22 135 Review Track For 30-day Notice
S007 2011-08-08 30-day Notice
S006 2011-04-21 30-day Notice
S005 2011-03-01 30-day Notice
S004 2010-12-20 30-day Notice
S003 2010-11-26 Normal 180 Day Track No User Fee
S002 2010-07-19 Normal 180 Day Track
S001

NIH GUDID Devices

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