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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.
 
DeviceLINOX SMART SD 60/16,LINOX SMART SD 65/16,LINOX SMART SD 65/18,LINOX SMART SD 75/18,LINOX SMART TD 65/16,LINOX SMART TD
Generic NamePermanent defibrillator electrodes
ApplicantBiotronik, Inc.
6024 Jean Rd.
Lake Oswego, OR 97035
PMA NumberP980023
Supplement NumberS068
Date Received05/27/2015
Decision Date06/22/2015
Product Code NVY 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
UPDATE THE BIOBURDEN TEST METHOD FOR ROUTINE MONITORING OF STERILIZED DEVICES.
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