PMA P130024S032
- Device
- Lutonix 018 Drug Coated Balloon PTA Catheters
- Applicant
- Lutonix
- PMA number
- P130024
- Supplement
- S032
- Product code
- ONU
- Decision date
- 2019-12-18
- Generic name
- Drug-Eluting Peripheral Transluminal Angioplasty Catheter
- Approval order statement
- Implement a minor change affecting the hub component of drug coated balloon catheter.
Current openFDA PMA Record#
- Device
- Lutonix 018 Drug Coated Balloon PTA Catheters
- Applicant
- Lutonix
- PMA number
- P130024
- Supplement
- S032
- Product code
- ONU
- Generic name
- Drug-Eluting Peripheral Transluminal Angioplasty Catheter
- Decision date
- 2019-12-18
- Decision code
- OK30
- Date received
- 2019-11-25
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Implement a minor change affecting the hub component of drug coated balloon catheter.