PMA P130024S045
- Device
- Lutonix™ 035 Drug Coated Balloon Catheter
- Applicant
- Lutonix
- PMA number
- P130024
- Supplement
- S045
- Product code
- ONU
- Decision date
- 2026-07-09
- Classification
- Cardiovascular
- Generic name
- Drug-Eluting Peripheral Transluminal Angioplasty Catheter
- Approval order statement
- Approval for a change in the paclitaxel (PTx) active pharmaceutical ingredient (API) supplier from Seripharm/NovaSep to Indena SpA.
Current openFDA PMA Record#
- Device
- Lutonix™ 035 Drug Coated Balloon Catheter
- Applicant
- Lutonix
- PMA number
- P130024
- Supplement
- S045
- Product code
- ONU
- Generic name
- Drug-Eluting Peripheral Transluminal Angioplasty Catheter
- Decision date
- 2026-07-09
- Decision code
- APPR
- Date received
- 2026-04-09
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for a change in the paclitaxel (PTx) active pharmaceutical ingredient (API) supplier from Seripharm/NovaSep to Indena SpA.