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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.
 
DeviceMARQUIS DR, MARQUIS VR, MAXIMO DR, MAXIMO VR, INTRINSIC 30, INTRINSIC, ENTRUST 30J/35J
Generic NameImplantable cardioverter defibrillator (non-CRT)
ApplicantMedtronic Cardiac Rhythm Disease Management
8200 Coral Sea St. N.E
Ms Mvs11
Mounds View, MN 55112
PMA NumberP980016
Supplement NumberS059
Date Received10/06/2005
Decision Date02/16/2006
Product Code LWS 
Advisory Committee Cardiovascular
Supplement Type135 Review Track For 30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR A CHANGE IN THE QUALITY INSPECTION PROCESS FOR THE TITANIUM CAN SEAM WELD ANALYSIS.
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