PMA P130024S030

Device: Lutonix 018 Drug Coated Balloon PTA Catheter (Lutonix 018 DCB)
Applicant: Lutonix
PMA number: P130024
Supplement: S030
Product code: ONU
Decision date: 2019-12-19
Generic name: Drug-Eluting Peripheral Transluminal Angioplasty Catheter
Approval order statement: Approval for the addition of a maximum balloon length of 300 mm for the 4, 5 and 6 mm balloon diameter sizes, a new colorant in the base catheter, and an increase in marker band length for the Lutonix 018 Drug Coated Balloon PTA Catheter indicated for use in native superficial femoral or popliteal arteries.

Current openFDA PMA Record#

Device: Lutonix 018 Drug Coated Balloon PTA Catheter (Lutonix 018 DCB)
Applicant: Lutonix
PMA number: P130024
Supplement: S030
Product code: ONU
Generic name: Drug-Eluting Peripheral Transluminal Angioplasty Catheter
Decision date: 2019-12-19
Decision code: APPR
Date received: 2019-09-20
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Approval for the addition of a maximum balloon length of 300 mm for the 4, 5 and 6 mm balloon diameter sizes, a new colorant in the base catheter, and an increase in marker band length for the Lutonix 018 Drug Coated Balloon PTA Catheter indicated for use in native superficial femoral or popliteal arteries.