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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 NameSECURA DR/VR/MAXIMO II VR/DR/VIRTUOSO II DR/VR ICDS
Classification Nameimplantable cardioverter defibrillator (non-crt)
Generic Namedual chamber icds
Applicant MEDTRONIC INC.
PMA NumberP980016
Supplement NumberS240
Date Received05/17/2010
Decision Date03/22/2011
Product Code
LWS[ Registered Establishments with LWS ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Review Memo Review Memo
Approval Order Statement 
Approval for the change of the materials, power supply, and incoming inspection process for the following avx capacitors to be used in the above referenced ipgs. Those capacitors are: xt009, xt045, xt082, xt096, xt113, xtc002, xtc018, xtc029, xt014, xt053, xt084, xt097, xt114, xtc004, xtc019, xtc030, xt017, xt058, xt085, xt099, xt116, xtc005, xtc020, xt023, xt060, xt086, xt103, xt118, xtc006, xtc021, xt027, xt067, xt087, xt104, xt120, xtc007, xtc023, xt032, xt068, xt088, xt105, xt121, xtc008, xtc024, xt038, xt070, xt090, xt106, xt122, xtc009, xtc025, xt041, xt072, xt091, xt108, xt123, xtc010, xtc026, xt043, xt077, xt092, xt109, xt124, xtc013, xtc027, xt044, xt078, xt095, xt110, xtc001, xtc017, xtc028, xt097, xt118, xt009, xt017, xt044, xt070, xt085, xt087, and xt114.
Approval Order Approval Order
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