Lutonix Drug Coated Balloon PTA Catheter
FDA premarket approval P130024/S029 · decided 2019-09-13
Approval details
- PMA number
- P130024
- Supplement
- S029
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- Lutonix Drug Coated Balloon PTA Catheter
- Generic name
- Drug-Eluting Peripheral Transluminal Angioplasty Catheter
- Applicant
- Lutonix
- Date received
- 2019-09-03
- Decision date
- 2019-09-13
- Days to decision
- 10 days
- Decision code
- APPR
- Product code
- ONU
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- New Hope, MN
- Statement
- Approval for updates to the device labeling.
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