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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 NameVENTRITEX SPL/TVL LED SYSTEM/ADX LEAD
Classification Nameimplantable cardioverter defibrillator (non-crt)
Generic Nametransvenous defibrillation lead
ApplicantST. JUDE MEDICAL, INC.
PMA NumberP950022
Supplement NumberS008
Date Received03/20/2000
Decision Date04/19/2000
Product Code
LWS[ Registered Establishments with LWS ]
Advisory Committee Anesthesiology
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Designation of alternate vendor of the silicone materials and medical adhesives used in the tvl and spl tachycardia leads.
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