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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.
 
DeviceLINOX SD IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LEADS
Classification Nameimplantable cardioverter defibrillator (non-crt)
Generic Nameimplantable cardioverter defibrillator (non-crt)
Applicant
BIOTRONIK, INC.
6024 jean road
lake oswego, OR 97035
PMA NumberP980023
Supplement NumberS020
Date Received09/06/2005
Decision Date01/27/2006
Product Code
LWS[ Registered Establishments with LWS ]
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 THE LINOX SD IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LEADS
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