Approval for a change to in-process testing procedures.
| Device | ASSURANT COBALT ILIAC BALLOON-EXPANDABLE STENT SYSTEM |
| Classification Name | Stent, Iliac |
| Generic Name | Stent, Iliac |
| Applicant | MEDTRONIC IRELAND |
| Date Received | 2015-02-12 |
| Decision Date | 2015-09-09 |
| PMA | P110011 |
| Supplement | S009 |
| Product Code | NIO |
| Advisory Committee | Cardiovascular |
| Supplement Type | 135 Review Track For 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