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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceChocolate Touch Paclitaxel Drug-Coated PTA Balloon Catheter (Chocolate Touch)
Generic NameDrug-Eluting Peripheral Transluminal Angioplasty Catheter
ApplicantTriReme Medical, LLC
7060 Koll Center Parkway, Suite 300
Pleasanton, CA 94566
PMA NumberP210039
Date Received12/27/2021
Decision Date11/04/2022
Product Code ONU 
Docket Number 22M-2824
Notice Date 11/18/2022
Advisory Committee Cardiovascular
Clinical TrialsNCT02924857
Expedited Review Granted? No
Combination ProductYes
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 OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Labeling Part 2
Post-Approval StudyShow Report Schedule and Study Progress
Supplements: S001  
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