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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 SD 60/16, Protego SD 65/16, Protego SD 65/18, Protego SD 75/18, Protego TD 65/16, Protego TD 65/18, Protego TD 7
Generic NameImplantable cardioverter defibrillator (non-CRT)
ApplicantBiotronik, Inc.
6024 Jean Rd.
Lake Oswego, OR 97035
PMA NumberP980023
Supplement NumberS077
Date Received08/01/2016
Decision Date08/22/2016
Product Code LWS 
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  
Addition of an alternate supplier for the DF4 connector.
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