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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, permanent, implantable
Generic Namepulse generator, permanent, implantable
8200 coral sea street ne
ms mv s11
mounds view, MN 55112
PMA NumberP980035
Supplement NumberS197
Date Received12/07/2010
Decision Date03/22/2011
Product Code
NVZ[ Registered Establishments with NVZ ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the design changes to the multilayer ceramic capacitors (xc308, xc251, xc259, and xc263) for concerto ii model d274trk; consulta model d224trk; and maximo ii modeld284trk; maximo ii models d284drg, d2s4vrc; secura models d224drg, d224vrc; andvirtuoso models d274drg. D274vrg; enrhythm model p1501dr; vitatron da+ c- series models c20a1, c20a3, c60a1, c60a3; and vitatron da+ t-series models t2oa1, t6oa1;.