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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.
 
DeviceENRYTHM IPG
Generic NameImplantable cardioverter defibrillator (non-CRT)
ApplicantMEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT
8200 CORAL SEA STREET N.E.
MS MVS11
MOUNDS VIEW, MN 55112
PMA NumberP980016
Supplement NumberS237
Date Received04/22/2010
Decision Date10/19/2010
Product Code LWS 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Review MemoReview Memo
Approval Order Statement  
APPROVAL FOR MODIFICATIONS TO THE MEDTRONIC ENRHYTHM PULSE GENERATORS AND ENTRUST (D153ATG, D153VRC, D154ATG, D154VRC, D154DRG) PROGRAMMER APPLICATION SOFTWARE MODEL 9987 (VERSION 7.2), MODEL 2491 DEVICE DATA MANAGEMENT APPLICATION (DDMA) (PART OF MODEL 2490G CARELINK MONITOR SYSTEM), FIRMWARE, AND THE POST STERILIZATION MANUFACTURING TEST SOFTWARE.
Approval OrderApproval Order
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