This medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original pma or panel track supplement and may not represent the most recent labeling.
Approval for the angiosculpt scoring balloon catheter. The device is indicated for the treatment of hemodynamically significant coronary artery stenosis, including in-stent restenosis and complex type c lesions, for the purpose of improving myocardial perfusion.
| 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 | 2005-05-11 |
| Decision Date | 2007-01-08 |
| Notice Date | 2007-01-23 |
| PMA | P050018 |
| Supplement | S |
| Product Code | NWX |
| Docket Number | 07M-0032 |
| Advisory Committee | Cardiovascular |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | SPECTRANETICS CORP. 5055 Brandin Court fremont, CA 94538 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling |
| Approval Order: | Approval Order |
| 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 |