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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 NameIS-1 CONNECTOR TERMINAL MODEL 6952 LEAD EXTENDER
Classification Nameimplantable cardioverter defibrillator (non-crt)
Generic Nametransvenous defibrillation lead; accessory stylets
ApplicantGUIDANT CORP.
PMA NumberP910073
Supplement NumberS033
Date Received07/12/2000
Decision Date09/12/2000
Product Code
LWS[ Registered Establishments with LWS ]
Advisory Committee Anesthesiology
Supplement Typereal-time process
Supplement Reason design change - minor
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for internal component changes to the is-1 connector terminal of the model 6952 lead extender.
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