PMA P980049S024

Device: ISOLINE 2CR DEFIBRILLATION LEADS MODELS 2CR5, 2CR6 AND 2CR7
Applicant: MicroPort CRM USA, Inc.
PMA number: P980049
Supplement: S024
Product code: MRM
Decision date: 2008-01-09
Classification: Defibrillator, Implantable, Dual-chamber
Generic name: DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
Approval order statement: APPROVAL FOR THE ISOLINE 2CT DEFIBRILLATION LEADS. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ISOLINE 2CT5 & 2CT6 TRANSVENOUS DEFIBRILLATION LEADS AND IS INDICATED TO PROVIDE RIGHT VENTRICULAR PACING, SENSING AND DEFIBRILLATION WHEN USED AS PART OF AN ELA MEDICAL IMPLANTABLE DEFIBRILLATOR.

Current openFDA PMA Record#

Device: ISOLINE 2CR DEFIBRILLATION LEADS MODELS 2CR5, 2CR6 AND 2CR7
Applicant: MicroPort CRM USA, Inc.
PMA number: P980049
Supplement: S024
Product code: MRM
Generic name: DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
Decision date: 2008-01-09
Decision code: APPR
Date received: 2006-10-16
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR THE ISOLINE 2CT DEFIBRILLATION LEADS. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ISOLINE 2CT5 & 2CT6 TRANSVENOUS DEFIBRILLATION LEADS AND IS INDICATED TO PROVIDE RIGHT VENTRICULAR PACING, SENSING AND DEFIBRILLATION WHEN USED AS PART OF AN ELA MEDICAL IMPLANTABLE DEFIBRILLATOR.