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.
Manufacturing transfer for the delivery systems of the devices within the same site.
| Device | RX HERCULINK ELITE RENAL STENT SYSTEM |
| Generic Name | Stent, Renal |
| Applicant | ABBOTT VASCULAR |
| Date Received | 2012-12-19 |
| Decision Date | 2013-01-24 |
| PMA | P110001 |
| Supplement | S010 |
| Product Code | NIN |
| Advisory Committee | Cardiovascular |
| Supplement Type | 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | ABBOTT VASCULAR 3200 Lakeside Drive santa Clara, CA 95054 |
| 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 |