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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 3 RF CRT-D SYSTEM
Classification Nameimplantable pulse generator, pacemaker (non-crt)
Generic Name pulse generator
ApplicantGUIDANT CORP.
PMA NumberP010012
Supplement NumberS044
Date Received03/04/2005
Decision Date08/15/2005
Product Code
LWP[ Registered Establishments with LWP ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for contak renewal 3 rf pulse generator software version 1. 2 and consult programmer software application model 2845 version 4. 12. Also approval to replace the existing polyimide tubing that provides insulation in the pulse generator header assembly with polyetheretherke-tone (peek) tubing.
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