PMA P130024S042

Device: Lutonix 035
Applicant: Lutonix
PMA number: P130024
Supplement: S042
Product code: ONU
Decision date: 2021-12-02
Generic name: Drug-Eluting Peripheral Transluminal Angioplasty Catheter
Approval order statement: Removal of a process documentation step for the vacuum drying process when no deviations from process parameters are identified during the automated cycle, to reduce redundancy.

Current openFDA PMA Record#

Device: Lutonix 035
Applicant: Lutonix
PMA number: P130024
Supplement: S042
Product code: ONU
Generic name: Drug-Eluting Peripheral Transluminal Angioplasty Catheter
Decision date: 2021-12-02
Decision code: OK30
Date received: 2021-11-18
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Removal of a process documentation step for the vacuum drying process when no deviations from process parameters are identified during the automated cycle, to reduce redundancy.