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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 NameINSYNC CRT-P & INSYNC III CRT-P
Classification Namedrug eluting permanent left ventricular (lv) pacemaker electrode
Applicant MEDTRONIC INC.
PMA NumberP010015
Supplement NumberS086
Date Received05/17/2010
Decision Date03/22/2011
Product Code
OJX[ Registered Establishments with OJX ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product Yes
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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