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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.
 
DeviceBELOS VR ICD SYSTEM
Generic NameTESTER, PACEMAKER ELECTRODE FUNCTION
ApplicantBiotronik, Inc.
6024 Jean Rd.
Lake Oswego, OR 97035
PMA NumberP980023
Supplement NumberS006
Date Received02/04/2002
Decision Date03/11/2002
Product Codes DTA DTE KRG LWS 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR PROGRAMMER SOFTWARE CARTRIDGE I-K01.0.A/4, MINOR EMBEDDED SOFTWARE CHANGES, MINOR HARDWARE CHANGES, AND A CORRECTION TO THE "USE BEFORE" DATE.
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