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.
Extension of the drug substance retest period and modification of heavy metals testing requirements.
| Device | Stellarex 0.035 OTW Drug-coated Angioplasty Ballon |
| Classification Name | Drug-eluting Peripheral Transluminal Angioplasty Catheter |
| Generic Name | Drug-eluting Peripheral Transluminal Angioplasty Catheter |
| Applicant | The Spectranetics Corp. |
| Date Received | 2019-04-08 |
| Decision Date | 2019-05-03 |
| PMA | P160049 |
| Supplement | S005 |
| Product Code | ONU |
| Advisory Committee | Cardiovascular |
| Supplement Type | 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | Yes |
| Applicant Address | The Spectranetics Corp. 6531 Dumbarton Circle fremont, CA 94555 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P160049 | Original Filing | |
| S019 | 2022-06-14 | 30-day Notice |
| S018 | 2022-04-01 | Normal 180 Day Track No User Fee |
| S017 | 2022-03-17 | 30-day Notice |
| S016 | ||
| S015 | 2021-09-29 | Panel Track |
| S014 | ||
| S013 | 2021-09-17 | Normal 180 Day Track No User Fee |
| S012 | 2021-05-07 | Normal 180 Day Track No User Fee |
| S011 | 2021-01-21 | 30-day Notice |
| S010 | ||
| S009 | ||
| S008 | 2020-01-15 | 30-day Notice |
| S007 | 2019-09-03 | Special (immediate Track) |
| S006 | 2019-05-13 | 30-day Notice |
| S005 | 2019-04-08 | 30-day Notice |
| S004 | ||
| S003 | 2018-10-01 | Normal 180 Day Track No User Fee |
| S002 | 2018-01-22 | Real-time Process |
| S001 | 2017-09-01 | Real-time Process |