PMA P170003S018
- Device
- Lutonix 018 Drug Coated Balloon PTA Catheter
- Applicant
- Lutonix
- PMA number
- P170003
- Supplement
- S018
- Product code
- PRC
- Decision date
- 2020-05-04
- Generic name
- Drug-coated peripheral transluminal angioplasty catheter
- Approval order statement
- Change in mixing ball used in the coating solution preparation process.
Current openFDA PMA Record#
- Device
- Lutonix 018 Drug Coated Balloon PTA Catheter
- Applicant
- Lutonix
- PMA number
- P170003
- Supplement
- S018
- Product code
- PRC
- Generic name
- Drug-coated 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.