LUTONIX 035 Drug Coated Balloon PTA Catheter
FDA premarket approval P130024/S031 · decided 2020-03-20
Approval details
- PMA number
- P130024
- Supplement
- S031
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - PAS
- Trade name
- LUTONIX 035 Drug Coated Balloon PTA Catheter
- Generic name
- Drug-Eluting Peripheral Transluminal Angioplasty Catheter
- Applicant
- Lutonix
- Date received
- 2019-09-23
- Decision date
- 2020-03-20
- Days to decision
- 179 days
- Decision code
- APPR
- Product code
- ONU
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- New Hope, MN
- Statement
- Approval for updates to the labeling.
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