Lutonix 035 Drug Coated Balloon PTA Catheter
FDA premarket approval P170003/S017 · decided 2020-05-14
Approval details
- PMA number
- P170003
- Supplement
- S017
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Lutonix 035 Drug Coated Balloon PTA Catheter
- Generic name
- Drug-coated peripheral transluminal angioplasty catheter
- Applicant
- Lutonix
- Date received
- 2020-03-12
- Decision date
- 2020-05-14
- Days to decision
- 63 days
- Decision code
- APPR
- Product code
- PRC
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- New Hope, MN
- Statement
- Approval for a new tie-layer material in the inner catheter shaft.
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