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.
| Device | RX Herculink Elite Renal Stent System |
| Generic Name | Stent, Renal |
| Applicant | ABBOTT VASCULAR3200 Lakeside Drivesanta Clara, CA 95054 PMA NumberP110001 Supplement NumberS018 Date Received02/28/2022 Decision Date03/24/2022 Product Code NIN Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No |
| Date Received | 2022-02-28 |
| Decision Date | 2022-03-24 |
| PMA | P110001 |
| Supplement | S018 |
| 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 PMA NumberP110001 Supplement NumberS018 Date Received02/28/2022 Decision Date03/24/2022 Product Code NIN Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductNo Approval Order Statement an Updated Sampling Plan For An In-process Device Testing |
| 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 |