Lutonix 035 (Model 9004 and Model 9010)
FDA premarket approval P130024/S044 · decided 2025-09-04
Approval details
- PMA number
- P130024
- Supplement
- S044
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Lutonix 035 (Model 9004 and Model 9010)
- Generic name
- Drug-Eluting Peripheral Transluminal Angioplasty Catheter
- Applicant
- Lutonix
- Date received
- 2025-08-08
- Decision date
- 2025-09-04
- Days to decision
- 27 days
- Decision code
- OK30
- Product code
- ONU
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- New Hope, MN
- Statement
- reducing the frequency of residual solvent testing from every individual lot to a single lot per month
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