PMA P130024S024
- Device
- Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB)
- Applicant
- Lutonix
- PMA number
- P130024
- Supplement
- S024
- Product code
- ONU
- Decision date
- 2018-09-10
- Classification
- Drug-eluting Peripheral Transluminal Angioplasty Catheter
- Generic name
- Drug-Eluting Peripheral Transluminal Angioplasty Catheter
- Approval order statement
- Approval for a change to the balloon wall thickness for the 6 x 220 mm and 7 x 80 - 220 mm balloon sizes as well as a reduction in the labeled introducer sheath compatibility of these device sizes.
Current openFDA PMA Record#
- Device
- Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB)
- Applicant
- Lutonix
- PMA number
- P130024
- Supplement
- S024
- Product code
- ONU
- Generic name
- Drug-Eluting Peripheral Transluminal Angioplasty Catheter
- Decision date
- 2018-09-10
- Decision code
- APPR
- Date received
- 2018-06-25
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for a change to the balloon wall thickness for the 6 x 220 mm and 7 x 80 - 220 mm balloon sizes as well as a reduction in the labeled introducer sheath compatibility of these device sizes.