PMA P170003S029
- Device
- Lutonix™ 018 Drug Coated Balloon PTA Catheter
- Applicant
- Lutonix
- PMA number
- P170003
- Supplement
- S029
- Product code
- PRC
- Decision date
- 2026-07-09
- Classification
- Cardiovascular
- Generic name
- Drug-coated 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™ 018 Drug Coated Balloon PTA Catheter
- Applicant
- Lutonix
- PMA number
- P170003
- Supplement
- S029
- Product code
- PRC
- Generic name
- Drug-coated 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.