Lutonix 035 Drug Coated Balloon PTA Catheter
FDA premarket approval P130024/S036 · decided 2020-05-04
Approval details
- PMA number
- P130024
- Supplement
- S036
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Lutonix 035 Drug Coated Balloon PTA Catheter
- Generic name
- Drug-Eluting Peripheral Transluminal Angioplasty Catheter
- Applicant
- Lutonix
- Date received
- 2020-04-13
- Decision date
- 2020-05-04
- Days to decision
- 21 days
- Decision code
- OK30
- Product code
- ONU
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- New Hope, MN
- Statement
- Change in mixing ball used in the coating solution preparation process.
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