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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 NameDURATA LEADS
Classification Namepermanent defibrillator electrodes
Generic Nametransvenous defibrillation lead
ApplicantST. JUDE MEDICAL, INC.
PMA NumberP950022
Supplement NumberS079
Date Received11/07/2011
Decision Date09/13/2012
Product Code
NVY[ Registered Establishments with NVY ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Approval for design changes to the helix-shaft subassembly of market approved tendril models 1882, 1888, 1988, 2088 and durata models 7120q, 7121q, 7122q, 7120, 7121, 7122, 7130, and 7131 leads for improved manufacturability and cost.
Approval Order Approval Order
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