COMPLETE SE VASCULAR STENT SYSTEM - SFA AND PPA

Stent, Superficial Femoral Artery

FDA Premarket Approval P110040 S009

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 stent manufacturing process.

DeviceCOMPLETE SE VASCULAR STENT SYSTEM - SFA AND PPA
Classification NameStent, Superficial Femoral Artery
Generic NameStent, Superficial Femoral Artery
ApplicantMedtronic Vascular
Date Received2016-05-05
Decision Date2016-06-01
PMAP110040
SupplementS009
Product CodeNIP
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
P110040Original Filing
S011 2016-08-17 135 Review Track For 30-day Notice
S010 2016-07-13 30-day Notice
S009 2016-05-05 30-day Notice
S008 2015-09-24 30-day Notice
S007 2015-06-15 Normal 180 Day Track No User Fee
S006 2015-03-20 135 Review Track For 30-day Notice
S005 2014-03-04 30-day Notice
S004 2014-01-30 30-day Notice
S003 2014-01-09 30-day Notice
S002 2013-12-16 30-day Notice
S001 2013-11-01 30-day Notice

NIH GUDID Devices

Device IDPMASupp
00643169150829 P110040 000
00643169150645 P110040 000
00643169150652 P110040 000
00643169150669 P110040 000
00643169150676 P110040 000
00643169150737 P110040 000
00643169150744 P110040 000
00643169150751 P110040 000
00643169150768 P110040 000
00643169150775 P110040 000
00643169150782 P110040 000
00643169150799 P110040 000
00643169150805 P110040 000
00643169150812 P110040 000
00643169150638 P110040 000

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