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.

• Device: ASSURANT COBALT ILIAC BALLOON-EXPANDABLE STENT SYSTEM
• Generic Name: Stent, Iliac
• Applicant: MEDTRONIC IRELAND
• Date Received: 2013-07-01
• Decision Date: 2013-07-26
• PMA: P110011
• Supplement: S003
• Product Code: NIO
• Advisory Committee: Cardiovascular
• Supplement Type: 30-day Notice
• Supplement Reason: Process Change - Manufacturer/sterilizer/packager/supplier
• Expedited Review: No
• Combination Product: No
• Applicant Address: MEDTRONIC IRELAND parkmore Business Park West galway

Supplemental Filings

Supplement Number	Date	Supplement Type
P110011		Original 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 ID	PMA	Supp
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