LUTONIX 035 DRUG COATED BALLOON PTA CATHETER
FDA premarket approval P130024/S010 · decided 2016-03-10
Approval details
- PMA number
- P130024
- Supplement
- S010
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- LUTONIX 035 DRUG COATED BALLOON PTA CATHETER
- Generic name
- Drug-Eluting Peripheral Transluminal Angioplasty Catheter
- Applicant
- Lutonix
- Date received
- 2016-01-27
- Decision date
- 2016-03-10
- Days to decision
- 43 days
- Decision code
- APPR
- Product code
- ONU
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- New Hope, MN
- Statement
- Approval to the addition of a new balloon folding process, implementation of a new in-process leak detection test, changes to the sampling plan for an in-process assay test, and labeling changes for sheath compatibility, crossing profile, and recommended balloon inflation time.
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