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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.
 
DeviceADAPTA, VERSA, SENSIA IPG, ADVISA DR IPG, ADVISA DR MRI IPG, ENTHYTHM, KAPPA D (KAPPA 700) IPG & KAPA
Generic NameImplantable pulse generator, pacemaker (non-CRT)
ApplicantMEDTRONIC Inc.
8200 CORAL SEA STREET NE
MS MV S11
MOUNDS VIEW, MN 55112
PMA NumberP980035
Supplement NumberS384
Date Received07/18/2014
Decision Date01/26/2015
Product Code LWP 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR THE MYCARELINK SMART MONITOR USED WITH THE DEVICE. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME MYCARELINK SMART MONITOR ANDTHE MYCARELINK HEART APPLICATION AND IS INDICATED FOR:PATIENT READER INDICATIONS FOR USE:THE PATIENT READER IS A PORTABLE ELECTRONIC DEVICE THAT COMMUNICATES WITH YOUR MEDTRONICIMPLANTED HEART DEVICE. THE APPLICATION ON SMART PHONE OR TABLET TRANSMITS IMPLANTED HEARTDEVICE DATA TO THE MEDTRONIC CARELINK NETWORK. MOBILE APPLICATION INDICATIONS FOR USE:THE MEDTRONIC MYCARELINK HEART APPLICATION TRANSMITS IMPLANTED HEART DEVICE DATA TO THE CARELINK NETWORK VIA A MOBILE DEVICE.
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