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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.
Classification Nameimplantable pulse generator, pacemaker (non-crt)
Generic Namepulse generator
PMA NumberP010012
Supplement NumberS189
Date Received07/22/2008
Decision Date11/17/2008
Product Code
LWP[ Registered Establishments with LWP ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Approval for the next generation (g2) rf communicator, model 6476, which in conjunction with the latitude system software, v5. 0, model 6488, will add latitude support for cognis teligen pgs.