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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.
 
DevicePROTEGO FAMILY OF ICD LEADS
Classification Namepermanent defibrillator electrodes
Generic Namepermanent defibrillator electrodes
Applicant
BIOTRONIK, INC.
6024 jean road
lake oswego, OR 97035
PMA NumberP980023
Supplement NumberS057
Date Received01/27/2014
Decision Date07/03/2014
Product Code
NVY[ Registered Establishments with NVY ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product Yes
Review Memo Review Memo
Approval Order Statement 
APPROVAL FOR THE DF4 VARIANTS OF THE CURRENTLY APPROVED ILESTO/IFORIAICDS/CRT-DS AND LINOXSMART ICD LEADS.
Approval Order Approval Order
Post-Approval StudyShow Report Schedule and Study Progress
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