PMA P130024S037
- Device
- Lutonix 018 Drug Coated Balloon PTA Catheter
- Applicant
- Lutonix
- PMA number
- P130024
- Supplement
- S037
- Product code
- ONU
- Decision date
- 2020-12-22
- Generic name
- Drug-Eluting Peripheral Transluminal Angioplasty Catheter
- Approval order statement
- Approval for extending the shelf life for the 4-6x300 mm balloon sizes from 24 to 36 months.
Current openFDA PMA Record#
- Device
- Lutonix 018 Drug Coated Balloon PTA Catheter
- Applicant
- Lutonix
- PMA number
- P130024
- Supplement
- S037
- Product code
- ONU
- Generic name
- Drug-Eluting Peripheral Transluminal Angioplasty Catheter
- Decision date
- 2020-12-22
- Decision code
- APPR
- Date received
- 2020-09-30
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for extending the shelf life for the 4-6x300 mm balloon sizes from 24 to 36 months.