PMA P170003S006
- Device
- Lutonix 018 Drug Coated Balloon PTA Catheter (Lutonix DCB)
- Applicant
- Lutonix
- PMA number
- P170003
- Supplement
- S006
- Product code
- PRC
- Decision date
- 2019-05-23
- Classification
- Drug-coated Peripheral Transluminal Angioplasty Catheter
- Generic name
- Drug-coated 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
- P170003
- Supplement
- S006
- Product code
- PRC
- Generic name
- Drug-coated 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).