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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 NameCONTAK RENEWAL AND CONTAK RENEWAL 3
Classification Nameimplantable pulse generator, pacemaker (non-crt)
Generic Namepulse generator
ApplicantGUIDANT CORP.
PMA NumberP010012
Supplement NumberS133
Date Received05/30/2006
Decision Date07/17/2006
Product Code
LWP[ Registered Establishments with LWP ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason labeling change - instructions
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for labeling changes to the contak renewal and contak renewal 3 to ensure consistency with the approved labeling for the contak renewal 3rf.
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