PMA P130024S026
- Device
- Lutonix 035 Drug Coated Balloon PTA Catheter
- Applicant
- Lutonix
- PMA number
- P130024
- Supplement
- S026
- Product code
- ONU
- Decision date
- 2019-02-14
- Classification
- Drug-eluting Peripheral Transluminal Angioplasty Catheter
- Generic name
- Drug-Eluting Peripheral Transluminal Angioplasty Catheter
- Approval order statement
- Approval for a shelf life extension to 24 months for devices with balloon sizes 4 x 220 mm and 5 x 220 mm (standard balloon) and 6 x 220 mm (low profile balloon).
Current openFDA PMA Record#
- Device
- Lutonix 035 Drug Coated Balloon PTA Catheter
- Applicant
- Lutonix
- PMA number
- P130024
- Supplement
- S026
- Product code
- ONU
- Generic name
- Drug-Eluting Peripheral Transluminal Angioplasty Catheter
- Decision date
- 2019-02-14
- Decision code
- APPR
- Date received
- 2018-11-16
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for a shelf life extension to 24 months for devices with balloon sizes 4 x 220 mm and 5 x 220 mm (standard balloon) and 6 x 220 mm (low profile balloon).