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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 DA + C-SERIESAND VITATRON DA + T-SERIES
Classification Namepulse generator, permanent, implantable
Generic Nameimplantable pacemaker pulse generator
Applicant MEDTRONIC INC.
PMA NumberP990001
Supplement NumberS080
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 - component
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 model d284trk; maximo ii models d284drg, d2s4vrc; secura models d224drg, d224vrc; and virtuoso models d274drg. D274vrg; enrhythm model p1501dr; vitatron da+ c- series models c20a1, c20a3, c60a1, c60a3; and vitatron da+ t-series models t2oa1, t6oa1;.
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