LUTONIX DRUG COATED BALLOON PTA CATETER
FDA premarket approval P130024 · decided 2014-10-09
Approval details
- PMA number
- P130024
- Trade name
- LUTONIX DRUG COATED BALLOON PTA CATETER
- Generic name
- Drug-Eluting Peripheral Transluminal Angioplasty Catheter
- Applicant
- Lutonix
- Date received
- 2013-11-25
- Decision date
- 2014-10-09
- Days to decision
- 318 days
- Decision code
- APPR
- Product code
- ONU
- Advisory committee
- Cardiovascular
- Expedited review
- Yes
- Location
- New Hope, MN
- Statement
- APPROVAL FOR THE LUTONIX 035 DRUG COATED BALLOON PTA CATHETER (LUTONIX DCB). THIS DEVICE IS INDICATED FOR PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY, AFTER PRE-DILATATION, OF DE NOVO OR RESTENOTIC LESIONS UP TO 150MM IN LENGTH IN NATIVE SUPERFICIAL FEMORAL OR POPLITEAL ARTERIES WITH REFERENCE VESSELDIAMETERS OF 4-6MM.
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