|
Device | MEDTRONIC CARELINK MONITOR, MYCARELINK PATIENT MONITOR |
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 | S344 |
Date Received | 11/16/2015 |
Decision Date | 02/05/2016 |
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 the Alert Management Feature for the CareLink Network. |