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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 Namedefibrillator, automatic implantable cardioverter, with cardiac resynchronization (crt-d)
Generic Namefinishing wire
ApplicantGUIDANT CORP.
PMA NumberP010012
Supplement NumberS016
Date Received10/07/2003
Decision Date10/24/2003
Product Code
NIK[ Registered Establishments with NIK ]
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 system guide and technical manuals for the contak renewal and contak renewal 3 systems.
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