|
Device | MEDTRONIC CARELINK DEVICE DATA MANAGEMENT APPLICATION (DDMA) |
Generic Name | Pulse generator, permanent, implantable |
Applicant | Medtronic, Inc. 8200 CORAL SEA STREET N.E. MOUNDS VIEW, MN 55112 |
PMA Number | P890003 |
Supplement Number | S188 |
Date Received | 03/31/2010 |
Decision Date | 05/11/2010 |
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 |
Approval Order Statement APPROVAL FOR UPDATES MADE TO THE PROGRAMMER APPLICATION SOFTWARE MODEL 9995 AND THE CARELINK DEVICE DATA MANAGEMENT APPLICATION (DDMA) IN RESPONSE TO ADVERSE FIELD EVENTS. |