PMA P130024S027
- Device
- Lutonix 018 Drug Coated Balloon PTA Catheter (Lutonix DCB)
- Applicant
- Lutonix
- PMA number
- P130024
- Supplement
- S027
- Product code
- ONU
- Decision date
- 2019-05-23
- Classification
- Drug-eluting Peripheral Transluminal Angioplasty Catheter
- Generic name
- Drug-Eluting Peripheral Transluminal Angioplasty Catheter
- Approval order statement
- Approval for the addition of 80, 100, 120, 150 and 220 mm balloon size lengths to the 7 mm diameter balloon on a .018 guidewire compatible catheter (Lutonix 018).
Current openFDA PMA Record#
- Device
- Lutonix 018 Drug Coated Balloon PTA Catheter (Lutonix DCB)
- Applicant
- Lutonix
- PMA number
- P130024
- Supplement
- S027
- Product code
- ONU
- Generic name
- Drug-Eluting Peripheral Transluminal Angioplasty Catheter
- Decision date
- 2019-05-23
- Decision code
- APPR
- Date received
- 2019-02-26
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for the addition of 80, 100, 120, 150 and 220 mm balloon size lengths to the 7 mm diameter balloon on a .018 guidewire compatible catheter (Lutonix 018).