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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.
 
DeviceDefibrillator, Implantable, Dual Chamber, Automatic Implantable Cardioverter with Cardiac Resynchronization
Generic NameDEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
ApplicantBiotronik, Inc.
6024 Jean Rd.
Lake Oswego, OR 97035
PMA NumberP050023
Supplement NumberS107
Date Received02/16/2017
Decision Date05/06/2017
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
Approval Order Statement  
Approval for PSW 1702.U programmer software including support for Multi-Pole Pacing (MPP.)
Post-Approval StudyShow Report Schedule and Study Progress
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