|
Device | LEGEND PLUS FAMILY OF PACEMAKERS |
Generic Name | Pulse generator, permanent, implantable |
Applicant | MEDTRONIC Inc. 8200 Coral Sea Street NE Mounds View, MN 55112 |
PMA Number | P930022 |
Supplement Number | S010 |
Date Received | 06/17/2009 |
Decision Date | 07/28/2009 |
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 VERSION 2.2 OF THE MODEL 9986 DESKTOP/BOSS SOFTWARE FOR THE MEDTRONIC CARELINK PROGRAMMER. |