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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 Namepulse-generator, single chamber, sensor driven, implantable
Generic Nameimplantable pacemaker pulse generator
PMA NumberP970013
Supplement NumberS006
Date Received02/17/2006
Decision Date07/28/2006
Product Code
LWO[ Registered Establishments with LWO ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - software
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the modifications to the programmer software, model 3307 v6. 1. 1c and model 3330 v4. 1. 1, to include the quickopt timing cycle feature.