Lutonix 035 Drug Coated Balloon PTA Catheter
FDA premarket approval P130024/S034 · decided 2020-05-14
Approval details
- PMA number
- P130024
- Supplement
- S034
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Lutonix 035 Drug Coated Balloon PTA Catheter
- Generic name
- Drug-Eluting 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
- ONU
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- New Hope, MN
- Statement
- Approval for a new tie-layer material in the inner catheter shaft.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.