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Device | LUTONIX® 035 Drug Coated Balloon PTA Catheter, Model 9010 |
Generic Name | Drug-coated peripheral transluminal angioplasty catheter |
Applicant | LUTONIX 9409 Science Center Drive New Hope, MN 55428 |
PMA Number | P170003 |
Date Received | 01/23/2017 |
Decision Date | 08/25/2017 |
Product Code |
PRC |
Docket Number | 17M-5334 |
Notice Date | 09/08/2017 |
Advisory Committee |
Cardiovascular |
Clinical Trials | NCT02440022
|
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement Approval for the LUTONIX® 035 Drug Coated Balloon PTA Catheter. This device is indicated for percutaneous transluminal angioplasty (PTA), after pre-dilatation, for the treatment of stenotic lesions in dysfunctional native arteriovenous dialysis fistulae that are 4 mm to 12 mm in diameter and up to 80 mm in length. |
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: |
S001 S002 S003 S004 S006 S007 S008 S011 S012 S014 S015 S016 S017 S018 S019 S021 S022 S023 S024 S025 S026 S027 |