Lutonix Drug Coated Balloon PTA Catheter
FDA premarket approval P170003/S024 · decided 2021-12-16
Approval details
- PMA number
- P170003
- Supplement
- S024
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Trade name
- Lutonix Drug Coated Balloon PTA Catheter
- Generic name
- Drug-coated peripheral transluminal angioplasty catheter
- Applicant
- Lutonix
- Date received
- 2021-09-24
- Decision date
- 2021-12-16
- Days to decision
- 83 days
- Decision code
- APPR
- Product code
- PRC
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- New Hope, MN
- Statement
- Approval of the revised protocol for the New Enrollment Post Approval Study Registry.
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