Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB)
FDA premarket approval P130024/S025 · decided 2018-12-18
Approval details
- PMA number
- P130024
- Supplement
- S025
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB)
- Generic name
- Drug-Eluting Peripheral Transluminal Angioplasty Catheter
- Applicant
- Lutonix
- Date received
- 2018-10-04
- Decision date
- 2018-12-18
- Days to decision
- 75 days
- Decision code
- APPR
- Product code
- ONU
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- New Hope, MN
- Statement
- Approval for the addition of 0.018 in guidewire compatibility catheter for the 4 to7 mm diameter balloon sizes, a 3rd radiopaque marker band for balloon lengths greater than 100 mm and a 150 cm length catheter.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.