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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.
 
DeviceCAPSUREFIX MRI LEAD,REVO MRI IPG
Generic NameImplantable pulse generator, pacemaker (non-CRT)
ApplicantMedtronic, Inc.
8200 Coral Sea St. N.E
Mounds View, MN 55112
PMA NumberP090013
Supplement NumberS119
Date Received10/24/2013
Decision Date11/19/2013
Product Codes NVN LWP 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
REMOVE THE ANNUAL REQUIREMENT FOR ETHYLENE OXIDE RESIDUAL TESTING AT MEDTRONIC FINAL DEVICE MANUFACTURING FACILITIES.
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