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 | Diamondback 360 Coronary Orbital Atherectomy System |
| Generic Name | Catheter, Coronary, Atherectomy |
| Applicant | CARDIOVASCULAR SYSTEMS, INC.651 Campus Drminneapolis, MN 55211 PMA NumberP130005 Supplement NumberS035 Date Received02/18/2022 Decision Date03/11/2022 Product Code MCX Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No |
| Date Received | 2022-02-18 |
| Decision Date | 2022-03-11 |
| PMA | P130005 |
| Supplement | S035 |
| Product Code | MCX |
| Advisory Committee | Cardiovascular |
| Supplement Type | 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | Yes |
| Applicant Address | CARDIOVASCULAR SYSTEMS, INC. 651 Campus Dr minneapolis, MN 55211 PMA NumberP130005 Supplement NumberS035 Date Received02/18/2022 Decision Date03/11/2022 Product Code MCX Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductYes Approval Order Statement introducing Alternate Suppliers For Different Non-patient-contacting Device Components |
| 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) |
| Device ID | PMA | Supp |
|---|---|---|
| 10850000491363 | P130005 | 000 |
| 10850000491356 | P130005 | 000 |
| 10850026568100 | P130005 | 000 |
| 10850026568087 | P130005 | 000 |
| 10850026568698 | P130005 | 000 |
| 10852528005442 | P130005 | 019 |
| 30852528005705 | P130005 | 021 |