ASSURANT COBALT ILIAC BALLOON-EXPANDABLE STENT SYSTEM

FDA Premarket Approval P110011 S003

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

Modifications to the stent subassembly annealing process and upgrades to an annealing oven.

DeviceASSURANT COBALT ILIAC BALLOON-EXPANDABLE STENT SYSTEM
Generic NameStent, Iliac
ApplicantMEDTRONIC IRELAND
Date Received2013-07-01
Decision Date2013-07-26
PMAP110011
SupplementS003
Product CodeNIO 
Advisory CommitteeCardiovascular
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address MEDTRONIC IRELAND parkmore Business Park West galway 

Supplemental Filings

Supplement NumberDateSupplement Type
P110011Original Filing
S013 2016-08-17 135 Review Track For 30-day Notice
S012 2016-07-13 30-day Notice
S011
S010 2015-03-20 135 Review Track For 30-day Notice
S009 2015-02-12 135 Review Track For 30-day Notice
S008 2014-12-12 30-day Notice
S007 2014-03-18 30-day Notice
S006 2013-12-16 30-day Notice
S005 2013-11-15 30-day Notice
S004 2013-08-19 30-day Notice
S003 2013-07-01 30-day Notice
S002 2012-03-22 135 Review Track For 30-day Notice
S001 2011-11-14 30-day Notice

NIH GUDID Devices

Device IDPMASupp
00613994931283 P110011 000
00613994931146 P110011 000
00613994931139 P110011 000
00613994931122 P110011 000
00613994931115 P110011 000
00613994931108 P110011 000
00613994931092 P110011 000
00613994931085 P110011 000
00613994931078 P110011 000
00613994931061 P110011 000
00613994931054 P110011 000
00613994931047 P110011 000
00613994931153 P110011 000
00613994931160 P110011 000
00613994931276 P110011 000
00613994931269 P110011 000
00613994931252 P110011 000
00613994931245 P110011 000
00613994931238 P110011 000
00613994931221 P110011 000
00613994931214 P110011 000
00613994931207 P110011 000
00613994931191 P110011 000
00613994931184 P110011 000
00613994931177 P110011 000
00613994931030 P110011 000

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