PMA P170003S026

Device: Lutonix Drug Coated Balloon PTA Catheter
Applicant: Lutonix
PMA number: P170003
Supplement: S026
Product code: PRC
Decision date: 2024-08-29
Classification: Cardiovascular
Generic name: Drug-coated peripheral transluminal angioplasty catheter
Approval order statement: approval for changes to the labeling of the Lutonix 035 Drug Coated Balloon (DCB) PTA Catheter (Model 9010) and Lutonix 018 DCB PTA Catheter (Model 9014) to include results of the Lutonix Global AV Registry

Current openFDA PMA Record#

Device: Lutonix Drug Coated Balloon PTA Catheter
Applicant: Lutonix
PMA number: P170003
Supplement: S026
Product code: PRC
Generic name: Drug-coated peripheral transluminal angioplasty catheter
Decision date: 2024-08-29
Decision code: APPR
Date received: 2023-03-09
Supplement type: Normal 180 Day Track
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: approval for changes to the labeling of the Lutonix 035 Drug Coated Balloon (DCB) PTA Catheter (Model 9010) and Lutonix 018 DCB PTA Catheter (Model 9014) to include results of the Lutonix Global AV Registry