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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 C LEAD, SQ PATCH LEAD, SQ LEAD ARRAY, DSP LEAD
Classification Nameimplantable cardioverter defibrillator (non-crt)
Generic Namenonthorocotomy leads for cardioverter
ApplicantGUIDANT CORP.
PMA NumberP910073
Supplement NumberS020
Date Received05/10/1996
Decision Date05/15/1996
Product Code
LWS[ Registered Establishments with LWS ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason labeling change - indications
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the endotak c lead (models 0060, 0062, 0064, 0065, 0066, 0067, and 0068), endotak sq patch lead (model 0047 and 0063), endotak c lead (models 0070, 0072, 0073, 0074, 0075, 0113, and 0115), endotak sq lead array (models 0048 and 0049), and endotak dsp lead (models 0092, 0093, 0094, 0095, 0096, 0097, 0123, and 0125), which requested approval to add a patient group to the indications for use.
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