SPRINTER MX2 BALLOON DILATATION CATHETER

FDA premarket approval P790017/S083 · decided 2005-06-22

Approval details

PMA number

P790017

Supplement

S083

Supplement type

Real-Time Process

Supplement reason

Change Design/Components/Specifications/Material

Trade name

SPRINTER MX2 BALLOON DILATATION CATHETER

Generic name

Catheters, transluminal coronary angioplasty, percutaneous

Applicant

Medtronic, Ireland

Date received

2004-12-10

Decision date

2005-06-22

Days to decision

194 days

Decision code

APPR

Product code

LOX

Advisory committee

Cardiovascular

Expedited review

No

Location

Galway

Statement

APPROVAL FOR ADDING A NEW CATHETER TO THE APPROVED PRODUCT LINE. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME SPRINTER MX2 AND IS INDICATED FOR BALLOON DILATATION FOR THE STENOTIC PORTION OF A CORONARY ARTERY OR BYPASS GRAFT STENOSIS FOR THE PURPOSE OF IMPROVING MYOCARDIAL PERFUSION. THE BALLOON DILATATION CATHETER (BALLOON MODELS 2.5 MM ? 4.0 MM) IS ALSO INDICATED FOR THE POST-DELIVERY EXPANSION OF BALLOON EXPANDABLE STENTS. NOTE: BENCH TESTING WAS CONDUCTED WITH THE SPRINTER

510(k) clearances by this applicant