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 protege gps and protege rx carotid stent systems. This device is indicated for used in conjunction with ev3 embolic protection devices, are indicated for the treatment of patients at high risk for adverse events from carotid endarterectomy who require percutaneous carotid revascularization and meet the following criteria:1) patients with carotid artery stenosis (>= 50% for symptomatic patients by ultrasound or angiography or >= 80% for asymptomatic patients by ultrasound or angiography) of the common or internal carotid artery, and2) patients must have a reference vessel diameter within the range of 4. 5 mm and 9. 5 mm at the target lesion.
| Device | PROTEGE GPS AND PROTEGE RX CAROTID STENT SYSTEMS |
| Classification Name | Stent, Carotid |
| Generic Name | Stent, Carotid |
| Applicant | MEDTRONIC VASCULAR INC |
| Date Received | 2006-01-09 |
| Decision Date | 2007-01-24 |
| Notice Date | 2007-02-09 |
| PMA | P060001 |
| Supplement | S |
| Product Code | NIM |
| Docket Number | 07M-0049 |
| Advisory Committee | Cardiovascular |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | MEDTRONIC VASCULAR INC 3033 Campus Drive plymouth, MN 55441 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling Labeling Part 2 |
| Post-Approval Study: | Show Report Schedule and Study Progress |
| Approval Order: | Approval Order |
| 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 |