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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.
 
DeviceSENSOLOG/ DIALOG/REGENCY FAMILY OF PACEMAKERS
Classification Nameimplantable pulse generator, pacemaker (non-crt)
Generic Nameimplantable pulse generator, pacemaker (non-crt)
Applicant
St. Jude Medical, Inc.
15900 valley view court
sylmar, CA 91342
PMA NumberP880006
Supplement NumberS081
Date Received07/11/2012
Decision Date04/10/2014
Product Code
LWP[ Registered Establishments with LWP ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Review Memo Review Memo
Approval Order Statement 
APPROVAL FOR THE MERLIN CONDUCT MOBILE SOFTWARE APPLICATION AND MODEL 3330 VERSION 16.1 SOFTWARE FOR THE MODEL 3650 MERLIN PATIENT CARE SYSTEM FOR THE DEVICES.
Approval Order Approval Order
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