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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 Nameimplantable cardioverter defibrillator (non-crt)
Generic Nameimplantable cardiac pacemaker pulse generator
ApplicantST. JUDE MEDICAL
PMA NumberP880006
Supplement NumberS072
Date Received06/28/2011
Decision Date08/17/2011
Product Code
LWS[ Registered Establishments with LWS ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason labeling change - instructions
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for minor modifications to the patient manuals packaged with the devices.
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