Lutonix 018 Drug Coated Balloon PTA Catheter
FDA premarket approval P170003/S018 · decided 2020-05-04
Approval details
- PMA number
- P170003
- Supplement
- S018
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Lutonix 018 Drug Coated Balloon PTA Catheter
- Generic name
- Drug-coated peripheral transluminal angioplasty catheter
- Applicant
- Lutonix
- Date received
- 2020-04-13
- Decision date
- 2020-05-04
- Days to decision
- 21 days
- Decision code
- OK30
- Product code
- PRC
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- New Hope, MN
- Statement
- Change in mixing ball used in the coating solution preparation process.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.