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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.
 
DeviceTVL(TM) LEAD SYSTEM
Generic NameImplantable cardioverter defibrillator (non-CRT)
ApplicantABBOTT MEDICAL
15900 Valley View Ct.
Sylmar, CA 91335
PMA NumberP950022
Supplement NumberS001
Date Received10/15/1996
Decision Date04/23/1997
Product Code LWS 
Docket Number N
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR RV LEAD MODEL RV03, SVC LEAD MODELS SV04 AND SV05 WITH A SOLID SUTURE SLEEVE, STYLET MODELS S-70-4, S-70-F, S-45-X, S-55-X AND S-70-X AND FOR USE OF A LSER PROCESS TO REMOVE EXCESS SILICONE RUBBER FROM THE DEFIBRILLATION COILS.
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