PMA P130024S005
- Device
- LUTONIX 035 DRUG COATED BALLOON PTA CATHETER
- Applicant
- Lutonix
- PMA number
- P130024
- Supplement
- S005
- Product code
- ONU
- Decision date
- 2015-11-20
- Classification
- Drug-eluting Peripheral Transluminal Angioplasty Catheter
- Generic name
- Drug-Eluting Peripheral Transluminal Angioplasty Catheter
- Approval order statement
- APPROVAL FOR THE ADDITION OF THE 7 X 40 MM AND 7 X 60 MM DEVICE SIZES. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME LUTONIX 035 DRUG COATED BALLOON PTA CATHETER AND 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 VESSEL DIAMETERS OF 4-7 MM.
Current openFDA PMA Record#
- Device
- LUTONIX 035 DRUG COATED BALLOON PTA CATHETER
- Applicant
- Lutonix
- PMA number
- P130024
- Supplement
- S005
- Product code
- ONU
- Generic name
- Drug-Eluting Peripheral Transluminal Angioplasty Catheter
- Decision date
- 2015-11-20
- Decision code
- APPR
- Date received
- 2015-06-02
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR THE ADDITION OF THE 7 X 40 MM AND 7 X 60 MM DEVICE SIZES. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME LUTONIX 035 DRUG COATED BALLOON PTA CATHETER AND 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 VESSEL DIAMETERS OF 4-7 MM.