Lutonix 018 Drug Coated Balloon PTA Catheter (Lutonix 018 DCB)
FDA premarket approval P130024/S030 · decided 2019-12-19
Approval details
- PMA number
- P130024
- Supplement
- S030
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Lutonix 018 Drug Coated Balloon PTA Catheter (Lutonix 018 DCB)
- Generic name
- Drug-Eluting Peripheral Transluminal Angioplasty Catheter
- Applicant
- Lutonix
- Date received
- 2019-09-20
- Decision date
- 2019-12-19
- Days to decision
- 90 days
- Decision code
- APPR
- Product code
- ONU
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- New Hope, MN
- Statement
- Approval for the addition of a maximum balloon length of 300 mm for the 4, 5 and 6 mm balloon diameter sizes, a new colorant in the base catheter, and an increase in marker band length for the Lutonix 018 Drug Coated Balloon PTA Catheter indicated for use in native superficial femoral or popliteal arteries.
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