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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(R) LEAD SYSTEM
Classification Nameimplantable cardioverter defibrillator (non-crt)
Generic Nameendocardial defibrillation leads
ApplicantCARDIAC PACEMAKERS, INC.
PMA NumberP910073
Supplement NumberS015
Date Received05/01/1995
Decision Date11/27/1995
Product Code
LWS[ Registered Establishments with LWS ]
Advisory Committee Anesthesiology
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the decrease in the lead body diameter to be a maximum diameter of 10 french and modifications in the lead components - the device, as modified, will be marketed under the trade name endotak dsp lead models 0092, 0093, 0094, 0095, 0096, 0097, 0123, and 0125.
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