Lutonix 035 Drug Coated Balloon PTA Catheters
FDA premarket approval P130024/S038 · decided 2021-08-06
Approval details
- PMA number
- P130024
- Supplement
- S038
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Lutonix 035 Drug Coated Balloon PTA Catheters
- Generic name
- Drug-Eluting Peripheral Transluminal Angioplasty Catheter
- Applicant
- Lutonix
- Date received
- 2021-01-08
- Decision date
- 2021-08-06
- Days to decision
- 210 days
- Decision code
- APPR
- Product code
- ONU
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- New Hope, MN
- Statement
- Approval to modify an in-process drug content inspection.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.