|
Device | MEDTRONIC CARELINK EXPRESS MONITORS, MODIFICATIONS T THE MEDTRONIC CARELINK REMOTE HOME MONITOR AND MEDTRONIC CARDIOSIGH |
Generic Name | Pulse generator, permanent, implantable |
Applicant | Medtronic, Inc. 8200 CORAL SEA STREET N.E. MOUNDS VIEW, MN 55112 |
PMA Number | P890003 |
Supplement Number | S228 |
Date Received | 05/25/2011 |
Decision Date | 08/25/2011 |
Product Code |
NVZ |
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 MODELS 2020B/C MEDTRONIC CARELINK EXPRESS MONITORS AND MODIFICATIONS TO THE MODEL 2490/G/H/J MEDTRONIC CARELINK REMOTE HOME MONITOR AND MODEL 2020A MEDTRONIC CARDIOSIGHT READER TO UPDATE DEVICE FIRMWARE. |