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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.
 
DeviceILESTO 7/ 5 VR-T ICD, IFORIA 7/ 5 VR-T ICD, ILESTO 7/ 5 VR-T DX ICD, ILFORIA 7/ 5 VR-T DX ICD, ILESTO 7/ 5 DR-T ICD
Generic NameDEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
ApplicantBIOTRONIK, INC.
6024 Jean Road
Lake Oswego, OR 97035
PMA NumberP050023
Supplement NumberS058
Date Received12/18/2012
Decision Date03/18/2013
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
Review MemoReview Memo
RecallsCDRH Recalls
Approval Order Statement  
APPROVAL FOR THE ILESTO 7/5 VR-T ICD, ILESTO 7/5VR-T DX ICD, ILESTO 7/5 DR-T ICD, ILESTO 7/5 HFT CRT-D; IFORIA 7/5 VR-T ICD, IFORIA 7/5 VR-T DX ICD, IFORIA 7/5 DR-T ICD, IFORIA 7/5 HF-T CRT-D; AND THE PSW 1205.U.
Approval OrderApproval Order
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