Biosense Webster NOGA XP Cardiac Navigation System with Qwikmap™ Software and Injection Cardiology Catheter

מדינה: סינגפור

שפה: אנגלית

מקור: HSA (Health Sciences Authority)

זמין מ:

Johnson & Johnson International (Singapore) Pte Ltd

סיווג:

Class D medical device

תוצרת:

Biosense Webster, Inc.

איזור תרפויטי:

Cardiovascular

סממני תרפויטית:

The intended use of the NOGA XP Cardiac Navigation System with QwikMap Software is catheter-based cardiac electromechanical mapping. The NOGA XP Cardiac Navigation System with QwikMap Software allows real time display of cardiac maps in a number of different formats. Maps may be displayed as cardiac electrical activation maps, cardiac electrical propagation maps, cardiac electrical potential maps, cardiac chamber geometry maps, cardiac dynamic maps, cardiac hemodynamic maps, and cardiac electromechanical maps. The acquired patient signals, including body surface ECG and intracardiac electrograms may also be displayed in real time on the display screen. The Injection Cardiology Catheter is indicated for use in conjunction with a Biosense Webster reference device and the Biosense Webster NOGA® cardiac navigation system for injecting agents into the myocardium

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Device System Info:[System or Procedure Pack], [Sterile Medical Device], Noga-Star Catheter and Injection Cardiology Catheter is Ethylene Oxide sterilised. The NOGA XP Cardiac Navigation System is non sterile.; Models: NOGA® XP Cardiac Navigation System with Qwikmap™ Software - M572401; NOGAXP, Noga-Star™ Cardiology Catheter Deflectable Braided Tip B-Type - 120705S; 34O-11M, Noga-Star™ Cardiology Catheter Deflectable Braided Tip C-Type - 120706S; 34O-21M, Noga-Star™ Cardiology Catheter Deflectable Braided Tip D-Type - 120707S; 34O-31M, Noga-Star™ Cardiology Catheter Deflectable Braided Tip F-Type - 120708S; 34O-51M, Myostar Injection Catheter: Defelectable Braided Tip B-Type - 121117S; 34S15M, Injection Cardiology Catheter: Defelectable Braided Tip C-Type - 121118S; 34S25M, Myostar Injection Catheter: Defelectable Braided Tip D-Type - 121119S;34S35M, Myostar Injection Catheter: Defelectable Braided Tip F-Type - 121120S; 34S55M, RefStar® Plus QwikPatch™ Electrophysiology Catheter External Reference Patch - D-1210-03; XRPP8Y, RefStar® Plus Cable - M-4700-106; C1MHREFFY

תאריך אישור:

2010-09-30