Chocolate Touch Paclitaxel Drug-Coated PTA Balloon Catheter (Chocolate Touch)

FDA Premarket Approval P210039

Pre-market Approval Supplement Details

• Device: Chocolate Touch Paclitaxel Drug-Coated PTA Balloon Catheter (Chocolate Touch)
• Generic Name: Drug-eluting Peripheral Transluminal Angioplasty Catheter
• Applicant: TriReme Medical, LLC7060 Koll Center Parkway, Suite 300pleasanton, CA 94566 PMA NumberP210039 Date Received12/27/2021 Decision Date11/04/2022 Product Code ONU Advisory Committee Cardiovascular Clinical TrialsNCT02924857 Expedited Review Granted? No
• Date Received: 2021-12-27
• Decision Date: 2022-11-04
• PMA: P210039
• Supplement: S
• Product Code: ONU
• Advisory Committee: Cardiovascular
• Expedited Review: No
• Combination Product: Yes
• Applicant Address: TriReme Medical, LLC; 7060 Koll Center Parkway, Suite 300; pleasanton, CA 94566 PMA NumberP210039 Date Received12/27/2021 Decision Date11/04/2022 Product Code ONU Advisory Committee Cardiovascular Clinical TrialsNCT02924857; Expedited Review Granted? No Combination ProductYes Approval Order Statement ; The Chocolate Touch® (Paclitaxel Coated PTA Balloon Catheter) 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. Supplements:

Supplemental Filings

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Supplement Number	Date	Supplement Type
P210039		Original Filing