Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB)
FDA premarket approval P130024/S024 · decided 2018-09-10
Approval details
- PMA number
- P130024
- Supplement
- S024
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB)
- Generic name
- Drug-Eluting Peripheral Transluminal Angioplasty Catheter
- Applicant
- Lutonix
- Date received
- 2018-06-25
- Decision date
- 2018-09-10
- Days to decision
- 77 days
- Decision code
- APPR
- Product code
- ONU
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- New Hope, MN
- Statement
- Approval for a change to the balloon wall thickness for the 6 x 220 mm and 7 x 80 - 220 mm balloon sizes as well as a reduction in the labeled introducer sheath compatibility of these device sizes.
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