|
Device | VARIOUS FAMILIES OF PACEMAKERS |
Generic Name | Pulse-generator, single chamber, sensor driven, implantable |
Applicant | MEDTRONIC Inc. 8200 Coral Sea Street NE Mounds View, MN 55112 |
PMA Number | P850051 |
Supplement Number | S061 |
Date Received | 12/09/2005 |
Decision Date | 05/12/2006 |
Product Code |
LWO |
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 MEDTRONIC MODEL 2091 WB WIRELESS PC CARD FOR USE WITH MEDTRONIC MODEL 9986 DESKTOP/BOSS (SW VERSION 1.5) FOR THE MEDTRONIC CARELINK PROGRAMMER (MODEL 2090) FOR ALL MEDTRONIC AND VITATRON PACEMAKER AND ICD MODELS |