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Device | Chocolate Touch Paclitaxel Drug-Coated PTA Balloon Catheter (Chocolate Touch) |
Generic Name | Drug-Eluting Peripheral Transluminal Angioplasty Catheter |
Applicant | TriReme Medical, LLC 7060 Koll Center Parkway, Suite 300 Pleasanton, CA 94566 |
PMA Number | P210039 |
Date Received | 12/27/2021 |
Decision Date | 11/04/2022 |
Product Code |
ONU |
Docket Number | 22M-2824 |
Notice Date | 11/18/2022 |
Advisory Committee |
Cardiovascular |
Clinical Trials | NCT02924857
|
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement Approval of the Chocolate Touch® (Paclitaxel Coated PTA Balloon Catheter). The device is indicated for percutaneous transluminal angioplasty, after appropriate vessel preparation, of de novo or restenotic lesions up to 180 mm in length in native femoral or popliteal arteries with reference vessel diameters of 4.0 mm to 6.0 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: |
S001 |