LUTONIX® 035 Drug Coated Balloon PTA Catheter, Model 9010
FDA premarket approval P170003 · decided 2017-08-25
Approval details
- PMA number
- P170003
- Trade name
- LUTONIX® 035 Drug Coated Balloon PTA Catheter, Model 9010
- Generic name
- Drug-coated peripheral transluminal angioplasty catheter
- Applicant
- Lutonix
- Date received
- 2017-01-23
- Decision date
- 2017-08-25
- Days to decision
- 214 days
- Decision code
- APPR
- Product code
- PRC
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- New Hope, MN
- Statement
- Approval for the LUTONIX® 035 Drug Coated Balloon PTA Catheter. This device is indicated for percutaneous transluminal angioplasty (PTA), after pre-dilatation, for the treatment of stenotic lesions in dysfunctional native arteriovenous dialysis fistulae that are 4 mm to 12 mm in diameter and up to 80 mm in length.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.