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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.
 
DeviceMicra TPS
Generic NameLeadless pacemaker
Regulation Number870.3610
ApplicantMEDTRONIC Inc.
8200 CORAL SEA STREET NE
MS MV S11
MOUNDS VIEW, MN 55112
PMA NumberP150033
Supplement NumberS042
Date Received09/26/2018
Decision Date10/18/2018
Product Code PNJ 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductYes
Approval Order Statement  
Transfer receiving and incoming inspection activities for device components from Medtronic Rice Creek to Medtronic Puerto Rico Operations Company (MPROC) Villalba/Juncos sites and the FedEx/3PL (Third Party Logistics) facility in Guaynabo, Puerto Rico.
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