PMA P170003S016

Device: Lutonix 018 Drug Coated Balloon PTA Catheter (Lutonix 018 DCB)
Applicant: Lutonix
PMA number: P170003
Supplement: S016
Product code: PRC
Decision date: 2020-04-21
Generic name: Drug-coated peripheral transluminal angioplasty catheter
Approval order statement: Approval for a new colorant in the base catheter and an increase in marker band length for the Lutonix 018 Drug Coated Balloon PTA Catheter.

Current openFDA PMA Record#

Device: Lutonix 018 Drug Coated Balloon PTA Catheter (Lutonix 018 DCB)
Applicant: Lutonix
PMA number: P170003
Supplement: S016
Product code: PRC
Generic name: Drug-coated peripheral transluminal angioplasty catheter
Decision date: 2020-04-21
Decision code: APPR
Date received: 2020-01-21
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Approval for a new colorant in the base catheter and an increase in marker band length for the Lutonix 018 Drug Coated Balloon PTA Catheter.