PMA P170003S028
- Device
- Lutonix 018 (Model 9014)
- Applicant
- Lutonix
- PMA number
- P170003
- Supplement
- S028
- Product code
- PRC
- Decision date
- 2025-09-04
- Classification
- Cardiovascular
- Generic name
- Drug-coated peripheral transluminal angioplasty catheter
- Approval order statement
- reducing the frequency of residual solvent testing from every individual lot to a single lot per month
Current openFDA PMA Record#
- Device
- Lutonix 018 (Model 9014)
- Applicant
- Lutonix
- PMA number
- P170003
- Supplement
- S028
- Product code
- PRC
- Generic name
- Drug-coated peripheral transluminal angioplasty catheter
- Decision date
- 2025-09-04
- Decision code
- OK30
- Date received
- 2025-08-08
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- reducing the frequency of residual solvent testing from every individual lot to a single lot per month