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.
For a manufacturing site located at philips image guided therapy corporation, 5905 nathan lane north plymouth, mn 55442, for manufacturing, including finished lot release testing and finished product testing, for the stellarex 035 drug coated balloon.
| Device | Stellarex™ 0.035” OTW Drug-coated Angioplasty Balloon |
| Generic Name | Drug-eluting Peripheral Transluminal Angioplasty Catheter |
| Applicant | The Spectranetics Corp. |
| Date Received | 2021-05-07 |
| Decision Date | 2021-10-28 |
| PMA | P160049 |
| Supplement | S012 |
| Product Code | ONU |
| Advisory Committee | Cardiovascular |
| Supplement Type | Normal 180 Day Track No User Fee |
| Supplement Reason | Location 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 |