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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.
 
DeviceINSTENSIA ICD
Generic NameDEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
ApplicantMicroPort CRM USA, Inc.
5640 Airline Rd..
Arlington, TN 38002
PMA NumberP980049
Supplement NumberS099
Date Received05/15/2014
Decision Date11/04/2014
Product Code MRM 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
RecallsCDRH Recalls
Approval Order Statement  
APPROVAL FOR THE INTENSIA ICD AND CRT-D DEVICES.
Approval OrderApproval Order
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