|
Device | MEDTRONIC MODELS 2490C CARELINK REMOTE HOME MONITORS |
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 | S283 |
Date Received | 08/06/2013 |
Decision Date | 10/07/2013 |
Product Code |
OSR |
Advisory Committee |
Cardiovascular |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL FOR A FIRMWARE UPDATE TO THE MODEL 2490C CARELINK REMOTE HOME MONITOR FOR THE DEVICES. |