Approval for a change to the sealing process for the nosecone-to-glue plug and glue plug-to-saline sheath bonds to use light within a narrower ultraviolet (uv) wavelength for curing the sealing adhesive.
| Device | DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM (OAS) |
| Classification Name | Catheter, Coronary, Atherectomy |
| Generic Name | Catheter, Coronary, Atherectomy |
| Applicant | CARDIOVASCULAR SYSTEMS, INC. |
| Date Received | 2014-12-11 |
| Decision Date | 2015-05-14 |
| PMA | P130005 |
| Supplement | S004 |
| Product Code | MCX |
| Advisory Committee | Cardiovascular |
| Supplement Type | 135 Review Track For 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 |
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