NC STORMER OVER-THE-WIRE BALLOON DILATATION CATHETER AND NC STORMER ZIPPER MX BALLOON DILATATION CATHETER

FDA premarket approval P790017/S079 · decided 2003-03-04

Approval details

PMA number

P790017

Supplement

S079

Supplement type

Real-Time Process

Supplement reason

Change Design/Components/Specifications/Material

Trade name

NC STORMER OVER-THE-WIRE BALLOON DILATATION CATHETER AND NC STORMER ZIPPER MX BALLOON DILATATION CATHETER

Generic name

Catheters, transluminal coronary angioplasty, percutaneous

Applicant

Medtronic, Ireland

Date received

2003-01-16

Decision date

2003-03-04

Days to decision

47 days

Decision code

APPR

Product code

LOX

Advisory committee

Cardiovascular

Expedited review

No

Location

Galway

Statement

APPROVAL TO MAKE MODIFICATIONS TO THE STORMER BALLOON DILATATION CATHETER WITH ZIPPER DELIVERY. THE DEVICES, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAMES NC STORMER OVER-THE-WIRE BALLOON DILATATION CATHETER AND NC STORMER ZIPPER MX BALLOON DILATATION CATHETER AND ARE INDICATED FOR BALLOON DILATATION OF THE STENOTIC PORTION OF A CORONARY ARTERY OR BYPASS GRAFT STENOSIS FOR THE PURPOSE OF IMPROVING MYOCARDIAL PERFUSION. THE NC STORMER BALLOON DILATATION CATHETER (BALLOON MODELS 2.5 MM - 4.0

510(k) clearances by this applicant