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

FDA Premarket Approval P210039

Pre-market Approval Supplement Details

DeviceChocolate Touch Paclitaxel Drug-Coated PTA Balloon Catheter (Chocolate Touch)
Generic NameDrug-eluting Peripheral Transluminal Angioplasty Catheter
ApplicantTriReme 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 Received2021-12-27
Decision Date2022-11-04
PMAP210039
SupplementS
Product CodeONU 
Advisory CommitteeCardiovascular
Expedited ReviewNo
Combination ProductYes
Applicant AddressTriReme 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 NumberDateSupplement Type
P210039Original Filing

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