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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
DeviceISOLINE 2CR DEFIBRILLATION LEADS
Classification Namedefibrillator, implantable, dual-chamber
Generic Namedefibrillator, implantable, dual-chamber
Applicant
SORIN GROUP- CRM
4 avenue reaumur
clamart cedex 92140
PMA NumberP980049
Supplement NumberS021
Date Received05/16/2005
Decision Date01/15/2008
Product Code
MRM[ Registered Establishments with MRM ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
APPROVAL FOR: 1) MODIFICATIONS TO THE SWIFT 1CT SERIES ICD LEAD TO CREATE A DUAL-COIL, INTEGRATED BIPOLAR, ACTIVE-FIXATION ICD LEAD. THE NEW LEAD WILL BE MARKETED UNDER THE NAME ISOLINE 2CR AND IS INDICATED FOR USE WITH ELA MEDICAL IMPLANTABLE DEFIBRILLATORS; 2) MANUFACTURING SITE AT SORIN BIOMEDICA CRM SRL, SALUGGIA, ITALY AND TWO STERILIZATION SITES AT BIOSTER SPA, BERGAMO, ITALY.
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