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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.
 
DeviceCADENCE TIERED THERAPY DEFIBRILLATOR SYSTEM
Classification Nameimplantable cardioverter defibrillator (non-crt)
Generic Nameimplantable cardioverter defibrillator (non-crt)
Applicant
St. Jude Medical
15900 valley view ct.
sylmar, CA 91342-3577
PMA NumberP910023
Supplement NumberS048
Date Received08/11/2000
Decision Date09/07/2000
Product Code
LWS[ Registered Establishments with LWS ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason location change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
APPROVAL FOR THE ALTERNATE MANUFACTURING FACILITY AT INNOMEDICA, INC., MINNEAPOLIS, MN AND THE ALTERNATE STERILIZATION FACILITY AT STERIS ISOMEDIX, MINNEAPOLIS, MN.
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