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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 NameVITATRON DIVA PACING SYSTEM
Classification Nameimplantable pacemaker pulse-generator
Regulation Number870.3610
ApplicantVITATRON, INC.
PMA NumberP990001
Supplement NumberS003
Date Received05/16/2000
Decision Date07/26/2000
Product Code
DXY[ Registered Establishments with DXY ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the parylene coated version of the selection afm 902 pulse generator and the model vsa02, version 6. 0 programmer software.
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