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 into the reduced eo gas concentration version of the bsc2000-2 sterilization cycle.
Device | Ranger™ Paclitaxel-Coated PTA Balloon Catheter |
Generic Name | Drug-eluting Peripheral Transluminal Angioplasty Catheter |
Applicant | Boston Scientific Corporation |
Date Received | 2021-12-20 |
Decision Date | 2022-01-18 |
PMA | P190019 |
Supplement | S010 |
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 |