Lutonix 035 Drug Coated Balloon PTA Catheter
FDA premarket approval P130024/S026 · decided 2019-02-14
Approval details
- PMA number
- P130024
- Supplement
- S026
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- Lutonix 035 Drug Coated Balloon PTA Catheter
- Generic name
- Drug-Eluting Peripheral Transluminal Angioplasty Catheter
- Applicant
- Lutonix
- Date received
- 2018-11-16
- Decision date
- 2019-02-14
- Days to decision
- 90 days
- Decision code
- APPR
- Product code
- ONU
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- New Hope, MN
- Statement
- Approval for a shelf life extension to 24 months for devices with balloon sizes 4 x 220 mm and 5 x 220 mm (standard balloon) and 6 x 220 mm (low profile balloon).
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