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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.
 
DeviceDRUG ELUTING PERMANENT RIGHT VENTRICULAR OR RIGHT ATRIAL PACEMAKER ELECTRODES, DEXTRUS, SETROX, TILDA, SAFIO
Generic NamePulse generator, permanent, implantable
ApplicantBiotronik, Inc.
6024 Jean Rd.
Lake Oswego, OR 97035
PMA NumberP950037
Supplement NumberS143
Date Received10/14/2014
Decision Date11/06/2014
Product Code NVZ 
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  
USE OF AN AUTOMATED PROCESS TO MEASURE THE RETRACTED AND EXTENDED LENGTHS AND ELECTRICAL RESISTANCE OF THE FIXATION HELIX USED IN THE LEADS.
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