Lutonix 035 Drug Coated Balloon PTA Catheter
FDA premarket approval P170003/S022 · decided 2021-09-07
Approval details
- PMA number
- P170003
- Supplement
- S022
- 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-coated peripheral transluminal angioplasty catheter
- Applicant
- Lutonix
- Date received
- 2021-06-24
- Decision date
- 2021-09-07
- Days to decision
- 75 days
- Decision code
- APPR
- Product code
- PRC
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- New Hope, MN
- Statement
- Approval for a shelf-life extension from 12 to 24 months for the 8-9 mm diameter devices and a shelf-life extension from 12 to 36 months for the 7x80 mm and 7x100 mm device sizes.
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