Lutonix Drug Coated Balloon PTA Catheter
FDA premarket approval P170003/S026 · decided 2024-08-29
Approval details
- PMA number
- P170003
- Supplement
- S026
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- Lutonix Drug Coated Balloon PTA Catheter
- Generic name
- Drug-coated peripheral transluminal angioplasty catheter
- Applicant
- Lutonix
- Date received
- 2023-03-09
- Decision date
- 2024-08-29
- Days to decision
- 539 days
- Decision code
- APPR
- Product code
- PRC
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- New Hope, MN
- Statement
- approval for changes to the labeling of the Lutonix 035 Drug Coated Balloon (DCB) PTA Catheter (Model 9010) and Lutonix 018 DCB PTA Catheter (Model 9014) to include results of the Lutonix Global AV Registry
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