SPRINTER OVER-THE-WIRE (OTW) BALLOON DILATATION CATHETER (MULTIPLE MODEL NUMBERS FOR THE 1.5 MM TO 4.0 MM DIAMETERS)

FDA premarket approval P790017/S081 · decided 2004-06-23

Approval details

PMA number

P790017

Supplement

S081

Supplement type

Real-Time Process

Supplement reason

Change Design/Components/Specifications/Material

Trade name

SPRINTER OVER-THE-WIRE (OTW) BALLOON DILATATION CATHETER (MULTIPLE MODEL NUMBERS FOR THE 1.5 MM TO 4.0 MM DIAMETERS)

Generic name

Catheters, transluminal coronary angioplasty, percutaneous

Applicant

Medtronic, Ireland

Date received

2003-12-26

Decision date

2004-06-23

Days to decision

180 days

Decision code

APPR

Product code

LOX

Advisory committee

Cardiovascular

Expedited review

No

Location

Galway

Statement

APPROVAL FOR MINOR DESIGN, PACKAGING AND LABELING CHANGES TO THE STORMER OTW BALLON DILATATION CATHETER INCLUDING THE ADDITION OF 6 MM AND 12 MM BALLOON LENGTHS. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME SPRINTER OTW BALLOON DILATATION CATHETER AND IS INDICATED AS FOLLOWS: FOR BALLOON DILATATION OF THE STENOTIC PORTION OF A CORONARY ARTERY OR BYPASS GRAFT STENOSIS FOR THE PURPOSE OF IMPROVING MYOCARDIAL PERFUSION. THE SPRINTER OTW BALLOON DILATATION CATHETER (BALLOON MODELS

510(k) clearances by this applicant