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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.
 
DeviceRF MARINR 5F SC, RF MARINR 5F SCXL, RF MARINR 5F SCXS, RF MARINR 5F SCXXL
Generic NameCardiac ablation percutaneous catheter
ApplicantMedtronic, Inc.
8200 Coral Sea St. N.E
Ms Mvs11
Mounds View, MN 55112
PMA NumberP930029
Supplement NumberS054
Date Received12/28/2015
Decision Date01/21/2016
Product Code LPB 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
REQUESTED UPDATES TO THE STAINLESS STEEL COMPONENT PASSIVATION PROCESSES FOR THE ABOVE REFERENCED DEVICES.
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