Approval for the ranger™ paclitaxel-coated pta balloon catheter. This device is indicated for percutaneous transluminal angioplasty (pta) of de novo or restenotic lesions up to 180 mm in length located in native superficial femoral and proximal popliteal arteries (sfa/ppa) with reference vessel diameters of 4 - 8 mm.
Device | Ranger™ Paclitaxel-Coated PTA Balloon Catheter |
Generic Name | Drug-eluting Peripheral Transluminal Angioplasty Catheter |
Applicant | Boston Scientific Corporation |
Date Received | 2019-07-22 |
Decision Date | 2020-10-30 |
PMA | P190019 |
Supplement | S |
Product Code | ONU |
Advisory Committee | Cardiovascular |
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 |