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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceISOLINE 2CR DEFIBRILLATION LEADS MODELS 2CR5, 2CR6 AND 2CR7
Generic NameDEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
ApplicantMicroPort CRM USA, Inc.
5640 Airline Rd..
Arlington, TN 38002
PMA NumberP980049
Supplement NumberS024
Date Received10/16/2006
Decision Date01/09/2008
Product Code MRM 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
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.
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