PMA P130024S044
- Device
- Lutonix 035 (Model 9004 and Model 9010)
- Applicant
- Lutonix
- PMA number
- P130024
- Supplement
- S044
- Product code
- ONU
- Decision date
- 2025-09-04
- Classification
- Cardiovascular
- Generic name
- Drug-Eluting 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 035 (Model 9004 and Model 9010)
- Applicant
- Lutonix
- PMA number
- P130024
- Supplement
- S044
- Product code
- ONU
- Generic name
- Drug-Eluting 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