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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceVIGILA AND VOLTA AND PASSIVE FIXATION BIPOLAR STEROID ELUTING ICD LEADS
Generic NamePermanent defibrillator electrodes
ApplicantBiotronik, Inc.
6024 Jean Rd.
Lake Oswego, OR 97035
PMA NumberP980023
Supplement NumberS046
Date Received11/14/2011
Decision Date02/22/2012
Product Code NVY 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
Review MemoReview 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 MAYBE USED WITH ANY MANUFACTURERS' ICDS; AND 3) ACCESSORY KITS FOR USE WITH THE VIGILA AND VOLTA LEADS.
Approval OrderApproval Order
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