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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.
 
DeviceKAINOX VCS,SLX 58/11-BP,SLX 58/13-BP,SLX 58/14-BP,SLX 58/15-BP,SLX 58/17-BP,LINOX S 65,LINOX S 75, LINOX T 65,LINOX T75,
Generic NamePermanent defibrillator electrodes
ApplicantBiotronik, Inc.
6024 Jean Rd.
Lake Oswego, OR 97035
PMA NumberP980023
Supplement NumberS051
Date Received01/14/2013
Decision Date02/19/2013
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  
RECLASSIFYING THE ENVIRONMENTAL CONDITIONS FROM CLASS D TO ISO 8 CLEANROOMS.
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