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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 NameVIGILA AND VOLTA AND PASSIVE FIXATION BIPOLAR STEROID ELUTING ICD LEADS
Classification Namepermanent defibrillator electrodes
Generic Nameimplantable cardioverter defibrillator
ApplicantBIOTRONIK, INC.
PMA NumberP980023
Supplement NumberS046
Date Received11/15/2011
Decision Date02/22/2012
Product Code
NVY[ Registered Establishments with NVY ]
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 following: 1) addition of trade names vigila and volta for the linox and linox smart defibrillation leads; 2) change to indications for use statement to clarify that the vigila and volta leads may be used with any manufacturers' icds; and 3) accessory kits for use with the vigila and volta leads.
Approval Order Approval Order
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