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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,PROTEGO SD (60/16)(65/16),(65/18)(75/18), PROTEGO TD (65/16)(65/18)(75/18), PROTEGO S (60/65/75)PROTEGO T 65
Generic NamePermanent defibrillator electrodes
ApplicantBiotronik, Inc.
6024 Jean Rd.
Lake Oswego, OR 97035
PMA NumberP980023
Supplement NumberS065
Date Received03/06/2015
Decision Date07/17/2015
Product Code NVY 
Advisory Committee Cardiovascular
Supplement Type135 Review Track For 30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR IMPLEMENTATION OF PARAMETRIC RELEASE IN PLACE OF CONVENTIONAL PRODUCT RELEASE IN THE STERILIZATION PROCESS FOR PERMANENT PACEMAKER AND DEFIBRILLATION LEADS.
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