PMA P130024S022

Device

Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB)

Applicant

Lutonix

PMA number

P130024

Supplement

S022

Product code

ONU

Decision date

2018-08-29

Classification

Drug-eluting Peripheral Transluminal Angioplasty Catheter

Generic name

Drug-Eluting Peripheral Transluminal Angioplasty Catheter

Approval order statement

Approval for an extension of the product matrix to include balloon lengths up to 220 mm for all diameters of the Lutonix 035 Drug Coated Balloon.

Summary

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