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.
Adoption of the ranger paclitaxel-coated pta balloon catheter and promus everolimus-eluting coronary stent system into the reduced eo gas concentration version of the bsc2000-2 sterilization cycle previously approved to sterilize other boston scientific corporation (bsc) products
| Device | Ranger Paclitaxel-Coated PTA Balloon Catheter |
| Generic Name | Drug-eluting Peripheral Transluminal Angioplasty Catheter |
| Applicant | Boston Scientific Corporation |
| Date Received | 2021-01-27 |
| Decision Date | 2021-02-24 |
| PMA | P190019 |
| Supplement | S006 |
| 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 | Boston Scientific Corporation three Scimed Place maple Grove, MN 55311-1566 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P190019 | Original Filing | |
| S017 | 2022-11-03 | 30-day Notice |
| S016 | 2022-10-17 | 30-day Notice |
| S015 | 2022-10-06 | 30-day Notice |
| S014 | 2022-09-15 | 30-day Notice |
| S013 | 2022-01-28 | 30-day Notice |
| S012 | 2022-01-25 | 30-day Notice |
| S011 | ||
| S010 | 2021-12-20 | 30-day Notice |
| S009 | 2021-03-24 | 30-day Notice |
| S008 | ||
| S007 | 2021-02-24 | 30-day Notice |
| S006 | 2021-01-27 | 30-day Notice |
| S005 | 2020-12-08 | 30-day Notice |
| S004 | 2020-11-25 | Normal 180 Day Track No User Fee |
| S003 | ||
| S002 | 2020-11-09 | 30-day Notice |
| S001 |