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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, CONTAK RENEWAL 3, CONTAK RENEWAL 3 HE, CONTAK RENEWAL E RF, CONTAK RENEWAL 3 RF HE W/CONSULT PROG SFTWR
Classification Nameimplantable pulse generator, pacemaker (non-crt)
Generic Name pulse generator
ApplicantGUIDANT CORP.
PMA NumberP010012
Supplement NumberS056
Date Received07/12/2005
Decision Date08/16/2005
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 1) an alternate magnetic reed switch manufactured by hermetic and an associated change to the equipment used in the rework of this component (only in contak renewal 3 rf models h210, h215, h250 & h255 and contak renewal 3 rf he models h217, h219, h257, & h259); and 2) consult programmer software application model 2845 version 4. 12.
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