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.
A change in the final device labeling software
| Device | AngioSculpt PTCA Scoring Balloon Catheter |
| Classification Name | Catheter, Percutaneous Transluminal Coronary Angioplasty (ptca), Cutting/scoring |
| Generic Name | Catheter, Percutaneous Transluminal Coronary Angioplasty (ptca), Cutting/scoring |
| Applicant | SPECTRANETICS CORP. |
| Date Received | 2019-08-01 |
| Decision Date | 2019-08-22 |
| PMA | P050018 |
| Supplement | S027 |
| Product Code | NWX |
| Advisory Committee | Cardiovascular |
| Supplement Type | 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | SPECTRANETICS CORP. 5055 Brandin Court fremont, CA 94538 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P050018 | Original Filing | |
| S031 | 2021-06-28 | 30-day Notice |
| S030 | ||
| S029 | ||
| S028 | 2020-08-24 | 30-day Notice |
| S027 | 2019-08-01 | 30-day Notice |
| S026 | ||
| S025 | 2018-09-20 | 30-day Notice |
| S024 | 2017-03-24 | 30-day Notice |
| S023 | ||
| S022 | 2016-06-08 | Real-time Process |
| S021 | 2016-03-28 | 30-day Notice |
| S020 | ||
| S019 | 2013-07-24 | 30-day Notice |
| S018 | 2012-11-30 | Normal 180 Day Track |
| S017 | 2012-05-10 | Normal 180 Day Track |
| S016 | 2011-11-16 | 30-day Notice |
| S015 | 2011-09-29 | 30-day Notice |
| S014 | 2011-04-13 | 30-day Notice |
| S013 | 2011-03-29 | 30-day Notice |
| S012 | 2010-12-02 | Normal 180 Day Track No User Fee |
| S011 | 2010-10-12 | 30-day Notice |
| S010 | 2010-08-12 | 30-day Notice |
| S009 | ||
| S008 | 2009-08-10 | Real-time Process |
| S007 | 2009-05-20 | Special (immediate Track) |
| S006 | 2009-05-18 | 135 Review Track For 30-day Notice |
| S005 | 2008-12-31 | 30-day Notice |
| S004 | 2008-03-12 | Normal 180 Day Track No User Fee |
| S003 | 2007-05-30 | Normal 180 Day Track No User Fee |
| S002 | 2007-04-04 | Real-time Process |
| S001 | 2007-02-07 | Real-time Process |