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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 NameDEMA, DIVA AND AFM PULSE GENERATORS
Classification Nameimplantable pacemaker pulse-generator
Regulation Number870.3610
ApplicantVITATRON, INC.
PMA NumberP990001
Supplement NumberS006
Date Received02/01/2001
Decision Date03/07/2001
Product Code
DXY[ Registered Establishments with DXY ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason change design/components/specifications - software
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the software version pro vit vsa02 v6. 1 dema, diva, and selection of afm pulse generators.
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