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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.
 
DeviceLLESTO, IFORIA, LUMAX,
Generic NameDEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
ApplicantBiotronik, Inc.
6024 Jean Rd.
Lake Oswego, OR 97035
PMA NumberP050023
Supplement NumberS067
Date Received06/14/2013
Decision Date07/30/2013
Product Code MRM 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR THE MINOR LABELING MODIFICATIONS/CORRECTIONS, WHICH INCLUDES AN UPDATE OF THE INDICATION FOR USE STATEMENTS (IFU) TO INCLUDE THE MARKET APPROVED DEVICES WITH THE SAME IFU, AND OTHER MINOR CORRECTIONS TO THE LABELING.
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