PMA P210039

Device: Chocolate Touch Paclitaxel Drug-Coated PTA Balloon Catheter (Chocolate Touch)
Applicant: Trireme Medical, LLC
PMA number: P210039
Product code: ONU
Decision date: 2023-08-16
Generic name: Drug-Eluting Peripheral Transluminal Angioplasty Catheter
Approval order statement: Approval for updated labeling, including the 24-month clinical study results, removed paclitaxel warning, and other minor modifications.

Current openFDA PMA Record#

Device: Chocolate Touch Paclitaxel Drug-Coated PTA Balloon Catheter (Chocolate Touch)
Applicant: Trireme Medical, LLC
PMA number: P210039
Supplement: S001
Product code: ONU
Generic name: Drug-Eluting Peripheral Transluminal Angioplasty Catheter
Decision date: 2023-08-16
Decision code: APPR
Date received: 2023-05-04
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Labeling Change - PAS
Approval order statement: Approval for updated labeling, including the 24-month clinical study results, removed paclitaxel warning, and other minor modifications.