Lutonix 018 Drug Coated Balloon PTA Catheter (Lutonix DCB)
FDA premarket approval P170003/S006 · decided 2019-05-23
Approval details
- PMA number
- P170003
- Supplement
- S006
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Lutonix 018 Drug Coated Balloon PTA Catheter (Lutonix DCB)
- Generic name
- Drug-coated peripheral transluminal angioplasty catheter
- Applicant
- Lutonix
- Date received
- 2019-02-26
- Decision date
- 2019-05-23
- Days to decision
- 86 days
- Decision code
- APPR
- Product code
- PRC
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- New Hope, MN
- Statement
- Approval for the addition of 80, 100, 120, 150 and 220 mm balloon size lengths to the 7 mm diameter balloon on a .018 guidewire compatible catheter (Lutonix 018).
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