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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 RENEW 3 RF
Classification Nameimplantable pulse generator, pacemaker (non-crt)
Generic Namepulse generator
ApplicantGUIDANT CORP.
PMA NumberP010012
Supplement NumberS151
Date Received06/18/2007
Decision Date08/24/2007
Product Code
LWP[ Registered Establishments with LWP ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the following changes to the contak renewal 3 rf models h210, h215, h217, and h219: 1) digital ic pad change to address premature battery depletion. 2) hybrid motherboard dfn trace re-routing from outside layer ?4? to an inside layer ?3? to reduce electrical field intensity and possible arcing. 3) trim target adjustment.
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