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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.
 
Trade NameISOLINE 2CR DEFIBRILLATION LEADS
Classification Namedefibrillator, implantable, dual-chamber
Generic Nameimplantable cardioverter-defibrillator with active housing
ApplicantELA MEDICAL, INC.
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 location change: sterilizer
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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