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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
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
Supplement NumberS001
Date Received05/04/2023
Decision Date08/16/2023
Product Code ONU 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Labeling Change - PAS
Expedited Review Granted? No
Combination ProductYes
Approval Order Statement  
Approval for updated labeling, including the 24-month clinical study results, removed paclitaxel warning, and other minor modifications.
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