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. |
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Device | MYCARELINK PATIENT MONITOR MODEL |
Generic Name | Pacemaker/icd/crt non-implanted components |
Applicant | Medtronic, Inc. 8200 CORAL SEA STREET N.E. MOUNDS VIEW, MN 55112 |
PMA Number | P890003 |
Supplement Number | S368 |
Date Received | 11/16/2016 |
Decision Date | 06/09/2017 |
Product Code |
OSR |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for hardware, firmware, labeling, and manufacturing changes to support replacing the Bluetooth (BT) Classic module with a BT Low Energy module in the monitor base station. |
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