Approval for the assurant cobalt iliac balloon-expandable stent system. This device is indicated for improving iliac luminal diameter in patients with de novo and restenotic lesions in the common and external iliac arteries, with reference vessel diameters between 6 mm and 10 mm and lesion lengths up to 61 mm. The stent is intended as a permanent implant.
| Device | ASSURANT COBALT ILIAC BALLOON-EXPANDABLE STENT SYSTEM |
| Classification Name | Stent, Iliac |
| Generic Name | Stent, Iliac |
| Applicant | MEDTRONIC IRELAND |
| Date Received | 2011-04-01 |
| Decision Date | 2011-10-26 |
| Notice Date | 2011-11-04 |
| PMA | P110011 |
| Supplement | S |
| Product Code | NIO |
| Docket Number | 11M-0791 |
| Advisory Committee | Cardiovascular |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | MEDTRONIC IRELAND parkmore Business Park West galway |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling |
| Approval Order: | Approval Order |
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