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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 NameSENSOLOG/DIALOG/REGENCY FAMILY OF PACEMAKERS
Classification Namedefibrillator, automatic implantable cardioverter, with cardiac resynchronization (crt-d)
Generic Nameimplantable cardiac pacemaker pulse generator
ApplicantST. JUDE MEDICAL
PMA NumberP880006
Supplement NumberS075
Date Received11/01/2011
Decision Date05/07/2012
Product Code
NIK[ Registered Establishments with NIK ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - software
Expedited Review Granted? No
Combination Product No
Review Memo Review Memo
Approval Order Statement 
Approval for lead failure detection and telemetry enhancements.
Approval Order Approval Order
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