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Device | Ranger™ Paclitaxel-Coated PTA Balloon Catheter |
Generic Name | Drug-Eluting Peripheral Transluminal Angioplasty Catheter |
Applicant | Boston Scientific Corporation Three Scimed Place Maple Grove, MN 55311-1566 |
PMA Number | P190019 |
Date Received | 07/22/2019 |
Decision Date | 10/30/2020 |
Product Code |
ONU |
Docket Number | 20M-2152 |
Notice Date | 11/02/2020 |
Advisory Committee |
Cardiovascular |
Clinical Trials | NCT03064126
|
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement 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 -7 mm. |
Approval Order | Approval Order |
Summary | Summary of Safety and Effectiveness |
Labeling | Labeling Labeling Part 2 |
Post-Approval Study | Show Report Schedule and Study Progress |
Supplements: |
S008 S009 S018 S004 S005 S019 S020 S023 S024 S014 S015 S011 S012 S013 S022 S006 S007 S016 S017 S001 S002 S003 S010 S025 S026 S027 S028 S029 S030 |