Approval for the diamondback 360 coronary orbital atherectomy system (oas). The device is indicated to facilitate stent delivery in patients with coronary artery disease (cad) who are acceptable candidates for percutaneous transluminal coronary angioplasty (ptca) or stenting due to de novo, severely calcified coronary artery lesions.
| Device | DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM |
| Classification Name | Catheter, Coronary, Atherectomy |
| Generic Name | Catheter, Coronary, Atherectomy |
| Applicant | CARDIOVASCULAR SYSTEMS, INC. |
| Date Received | 2013-03-15 |
| Decision Date | 2013-10-21 |
| Notice Date | 2013-10-30 |
| PMA | P130005 |
| Supplement | S |
| Product Code | MCX |
| Docket Number | 13M-1363 |
| Advisory Committee | Cardiovascular |
| Expedited Review | No |
| Combination Product | Yes |
| Applicant Address | CARDIOVASCULAR SYSTEMS, INC. 651 Campus Dr minneapolis, MN 55211 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling |
| Approval Order: | Approval Order |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P130005 | | Original Filing |
| S035 |
2022-02-18 |
30-day Notice |
| S034 | | |
| S033 |
2021-02-03 |
Real-time Process |
| S032 |
2020-12-18 |
30-day Notice |
| S031 |
2020-11-13 |
Special (immediate Track) |
| S030 |
2020-06-17 |
30-day Notice |
| S029 |
2020-03-26 |
Normal 180 Day Track |
| S028 |
2020-01-27 |
30-day Notice |
| S027 |
2019-04-17 |
Normal 180 Day Track |
| S026 | | |
| S025 |
2019-02-07 |
Real-time Process |
| S024 |
2018-03-15 |
Real-time Process |
| S023 | | |
| S022 |
2018-02-05 |
Normal 180 Day Track |
| S021 |
2017-12-26 |
Normal 180 Day Track |
| S020 |
2017-08-22 |
Real-time Process |
| S019 |
2017-08-04 |
Normal 180 Day Track |
| S018 |
2017-04-25 |
Normal 180 Day Track |
| S017 |
2017-03-29 |
Real-time Process |
| S016 |
2017-03-02 |
Real-time Process |
| S015 |
2016-11-28 |
Normal 180 Day Track No User Fee |
| S014 |
2016-08-11 |
Normal 180 Day Track |
| S013 |
2016-05-13 |
30-day Notice |
| S012 |
2016-03-23 |
Normal 180 Day Track |
| S011 |
2016-02-19 |
30-day Notice |
| S010 |
2015-12-23 |
30-day Notice |
| S009 |
2015-04-20 |
Real-time Process |
| S008 |
2015-04-10 |
Real-time Process |
| S007 |
2015-02-18 |
Normal 180 Day Track No User Fee |
| S006 |
2015-01-30 |
Real-time Process |
| S005 |
2014-12-18 |
135 Review Track For 30-day Notice |
| S004 |
2014-12-11 |
135 Review Track For 30-day Notice |
| S003 |
2014-09-02 |
30-day Notice |
| S002 |
2014-08-11 |
Normal 180 Day Track |
| S001 |
2014-07-28 |
Special (immediate Track) |
NIH GUDID Devices