This medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original pma or panel track supplement and may not represent the most recent labeling.
Approval for the rx herculink elite renal stent system. This device is indicated for use in patients with atherosclerotic disease of the renal arteries following sub-optimal percutaneous transluminal renal angioplasty (ptra) of a de novo or restenotic atherosclerotic lesion (= 50% residual stenosis, >= 20 mmhg peak systolic or >= 10 mmhg mean translesional pressure gradient, flow-limiting dissection, or timi [thrombolysis in myocardial infarction] flow
| Device | RX HERCULINK ELITE RENAL STENT SYSTEM |
| Generic Name | Stent, Renal |
| Applicant | ABBOTT VASCULAR |
| Date Received | 2011-01-03 |
| Decision Date | 2011-07-20 |
| Notice Date | 2011-08-01 |
| PMA | P110001 |
| Supplement | S |
| Product Code | NIN |
| Docket Number | 11M-0564 |
| Advisory Committee | Cardiovascular |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | ABBOTT VASCULAR 3200 Lakeside Drive santa Clara, CA 95054 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling |
| Post-Approval Study: | Show Report Schedule and Study Progress |
| Approval Order: | Approval Order |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P110001 | Original Filing | |
| S018 | 2022-02-28 | 30-day Notice |
| S017 | 2021-11-09 | 30-day Notice |
| S016 | 2021-09-28 | 30-day Notice |
| S015 | 2021-04-29 | 30-day Notice |
| S014 | 2021-04-29 | 30-day Notice |
| S013 | 2017-03-21 | 30-day Notice |
| S012 | 2015-02-25 | 30-day Notice |
| S011 | 2013-12-11 | Normal 180 Day Track No User Fee |
| S010 | 2012-12-19 | 30-day Notice |
| S009 | 2012-08-02 | Normal 180 Day Track No User Fee |
| S008 | 2012-07-20 | 30-day Notice |
| S007 | 2012-06-13 | 30-day Notice |
| S006 | 2012-06-11 | 30-day Notice |
| S005 | 2012-05-24 | 30-day Notice |
| S004 | 2012-05-11 | 30-day Notice |
| S003 | 2012-04-27 | Normal 180 Day Track No User Fee |
| S002 | 2011-11-21 | 30-day Notice |
| S001 | 2011-08-19 | 30-day Notice |