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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 NameENDOTAK: DSP, ENDURANCE EZ, AND ENDURANCE RX LEADS
Classification Nameimplantable cardioverter defibrillator (non-crt)
Generic Nametransvenous defibrillation lead; accessory stylets
ApplicantGUIDANT CORP.
PMA NumberP910073
Supplement NumberS038
Date Received11/21/2001
Decision Date01/11/2002
Product Code
LWS[ Registered Establishments with LWS ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason design change - minor
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the peek support clip for the endotak dsp lead models 0094, 0095, 0125, endotak endurance lead models 0134, 0135, 0136 and endotak endurance ez lead models 0154, 0155 and 0156.
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