Lutonix 018 (Model 9014)
FDA premarket approval P170003/S028 · decided 2025-09-04
Approval details
- PMA number
- P170003
- Supplement
- S028
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Lutonix 018 (Model 9014)
- Generic name
- Drug-coated 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
- PRC
- 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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