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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.
 
DeviceMULTI-PARTITION OPERATING ENVIRONMENT (MOE), VERSION 1.0
Generic NameImplantable cardioverter defibrillator (non-CRT)
ApplicantMicroPort CRM USA, Inc.
5640 Airline Rd..
Arlington, TN 38002
PMA NumberP970024
Supplement NumberS002
Date Received02/08/1999
Decision Date02/23/1999
Withdrawal Date10/03/2022
Product Code 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 Multi-partition Operating Environment version 1.0.
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