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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 PLATFORM
Classification Nameimplantable pacemaker pulse-generator
Regulation Number870.3610
ApplicantVITATRON, INC.
PMA NumberP990001
Supplement NumberS005
Date Received11/08/2000
Decision Date01/08/2001
Product Code
DXY[ Registered Establishments with DXY ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason labeling change - shelf-life
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for an extension of the shelf life date to 18 months from 12 months and related labeling changes.
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