PMA P130024S036
- Device
- Lutonix 035 Drug Coated Balloon PTA Catheter
- Applicant
- Lutonix
- PMA number
- P130024
- Supplement
- S036
- Product code
- ONU
- Decision date
- 2020-05-04
- Generic name
- Drug-Eluting Peripheral Transluminal Angioplasty Catheter
- Approval order statement
- Change in mixing ball used in the coating solution preparation process.
Current openFDA PMA Record#
- Device
- Lutonix 035 Drug Coated Balloon PTA Catheter
- Applicant
- Lutonix
- PMA number
- P130024
- Supplement
- S036
- Product code
- ONU
- Generic name
- Drug-Eluting Peripheral Transluminal Angioplasty Catheter
- Decision date
- 2020-05-04
- Decision code
- OK30
- Date received
- 2020-04-13
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Change in mixing ball used in the coating solution preparation process.