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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 NameCADENCE FAMILY OF IMPLANTABLE CARDIOVERTER DEFIBRILLATORS AND THE TVL LEAD SYSTEM
Classification Nameimplantable cardioverter defibrillator (non-crt)
Generic Namedual chamber implantable cardioverter defibrillator
ApplicantST. JUDE MEDICAL INC., CARDIAC RHYTHM MANAGEMENT D
PMA NumberP910023
Supplement NumberS050
Date Received12/19/2000
Decision Date01/18/2001
Product Code
LWS[ Registered Establishments with LWS ]
Advisory Committee Anesthesiology
Supplement Type30-day notice
Supplement Reason process change: sterilization
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Use of an alternate sterilization chamber for the icds and tachycardia leads and is also requesting approval for use of parametric release as an alternate to the current use of biological indicators in the release of sterilized products.
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