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 | Protégé GPS Self-Expanding Peripheral Stent System, Protégé RX Carotid Stent System |
| Generic Name | Stent, Carotid |
| Applicant | MEDTRONIC VASCULAR INC3033 Campus Driveplymouth, MN 55441 PMA NumberP060001 Supplement NumberS035 Date Received11/15/2022 Decision Date12/15/2022 Product Code NIM Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No |
| Date Received | 2022-11-15 |
| Decision Date | 2022-12-15 |
| PMA | P060001 |
| Supplement | S035 |
| Product Code | NIM |
| Advisory Committee | Cardiovascular |
| Supplement Type | 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | MEDTRONIC VASCULAR INC 3033 Campus Drive plymouth, MN 55441 PMA NumberP060001 Supplement NumberS035 Date Received11/15/2022 Decision Date12/15/2022 Product Code NIM Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductNo Approval Order Statement the Addition Of A New Electropolishing Station To The Manufacturing Process |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P060001 | Original Filing | |
| S035 | 2022-11-15 | 30-day Notice |
| S034 | 2022-05-25 | 30-day Notice |
| S033 | 2022-03-29 | Real-time Process |
| S032 | 2021-04-08 | 30-day Notice |
| S031 | 2020-12-10 | 30-day Notice |
| S030 | 2020-07-21 | 30-day Notice |
| S029 | 2020-05-06 | Real-time Process |
| S028 | 2019-05-24 | 30-day Notice |
| S027 | 2019-05-03 | 30-day Notice |
| S026 | 2017-11-03 | 30-day Notice |
| S025 | ||
| S024 | 2015-11-23 | 30-day Notice |
| S023 | 2015-03-16 | 30-day Notice |
| S022 | 2014-07-21 | 30-day Notice |
| S021 | 2014-06-05 | 30-day Notice |
| S020 | 2014-05-02 | Panel Track |
| S019 | 2013-01-30 | 30-day Notice |
| S018 | 2012-10-09 | 30-day Notice |
| S017 | 2012-08-21 | Normal 180 Day Track No User Fee |
| S016 | 2011-12-19 | 30-day Notice |
| S015 | ||
| S014 | 2011-05-31 | 30-day Notice |
| S013 | 2011-04-29 | 30-day Notice |
| S012 | 2011-04-27 | 30-day Notice |
| S011 | 2011-02-16 | Normal 180 Day Track No User Fee |
| S010 | 2010-09-07 | 30-day Notice |
| S009 | 2010-05-20 | 30-day Notice |
| S008 | 2010-03-29 | Special (immediate Track) |
| S007 | 2008-05-27 | 30-day Notice |
| S006 | 2008-05-16 | Normal 180 Day Track No User Fee |
| S005 | 2008-03-07 | 30-day Notice |
| S004 | 2007-12-31 | 30-day Notice |
| S003 | 2007-02-16 | Normal 180 Day Track No User Fee |
| S002 | 2007-01-31 | 135 Review Track For 30-day Notice |
| S001 | 2007-01-29 | 135 Review Track For 30-day Notice |