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.
Change to the limulus amebocyte lysate (lal) bacterial endotoxin test program.
| Device | ANGIOSCULPT 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 | 2016-03-28 |
| Decision Date | 2016-04-26 |
| PMA | P050018 |
| Supplement | S021 |
| 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 |