LUTONIX® 035 Drug Coated Balloon PTA Catheter
FDA premarket approval P170003/S011 · decided 2019-12-09
Approval details
- PMA number
- P170003
- Supplement
- S011
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- LUTONIX® 035 Drug Coated Balloon PTA Catheter
- Generic name
- Drug-coated peripheral transluminal angioplasty catheter
- Applicant
- Lutonix
- Date received
- 2019-09-11
- Decision date
- 2019-12-09
- Days to decision
- 89 days
- Decision code
- APPR
- Product code
- PRC
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- New Hope, MN
- Statement
- Approval for an extension to the device balloon size matrix (7.0, and 8.0 mm diameters in 80 and 100 mm lengths, 9.0 mm diameter in 80 mm length and 12.0 mm diameter available in 60 mm length) and a reduction in the cone angle for the 8 through 12 mm diameter balloons to accommodate a reduction in sheath compatibility.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.