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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 NumberS078
Date Received02/29/2012
Decision Date03/21/2012
Product Code
NIK[ Registered Establishments with NIK ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason change design/components/specifications - software
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the model 3330 version 13. 1. 0 software for the model 3650 merlin patient care system to be used with the sensolog/ dialog/regency family of pacemakers.
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