PMA P130024S034
- Device
- Lutonix 035 Drug Coated Balloon PTA Catheter
- Applicant
- Lutonix
- Product code
- ONU
- Decision date
- 2020-05-14
- Generic name
- Drug-Eluting Peripheral Transluminal Angioplasty Catheter
- Approval order statement
- Approval for a new tie-layer material in the inner catheter shaft.
Current openFDA PMA Record#
- Device
- Lutonix 035 Drug Coated Balloon PTA Catheter
- Applicant
- Lutonix
- PMA number
- P130024
- Supplement
- S034
- Product code
- ONU
- Generic name
- Drug-Eluting Peripheral Transluminal Angioplasty Catheter
- Decision date
- 2020-05-14
- Decision code
- APPR
- Date received
- 2020-03-12
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for a new tie-layer material in the inner catheter shaft.