Lutonix 018 Drug Coated Balloon PTA Catheter
FDA premarket approval P170003/S004 · decided 2018-12-18
Approval details
- PMA number
- P170003
- Supplement
- S004
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Lutonix 018 Drug Coated Balloon PTA Catheter
- Generic name
- Drug-coated peripheral transluminal angioplasty catheter
- Applicant
- Lutonix
- Date received
- 2018-10-04
- Decision date
- 2018-12-18
- Days to decision
- 75 days
- Decision code
- APPR
- Product code
- PRC
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- New Hope, MN
- Statement
- Approval for the addition of 0.018 in guidewire compatibility catheter for the 4 to 7 mm diameter balloon sizes, a 3rd radiopaque marker band for balloon lengths greater than 100 mm and a 150 cm length catheter.
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