Lutonix 018 and 035 Drug Coated Balloon
FDA premarket approval P130024/S040 · decided 2021-06-03
Approval details
- PMA number
- P130024
- Supplement
- S040
- Supplement type
- Real-Time Process
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Lutonix 018 and 035 Drug Coated Balloon
- Generic name
- Drug-Eluting Peripheral Transluminal Angioplasty Catheter
- Applicant
- Lutonix
- Date received
- 2021-03-08
- Decision date
- 2021-06-03
- Days to decision
- 87 days
- Decision code
- APPR
- Product code
- ONU
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- New Hope, MN
- Statement
- Approval for revised release specifications for related substances.
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