|
Device | GEM III AT FAMILY OF ICDS, JEWEL AF |
Generic Name | Implantable cardioverter defibrillator (non-CRT) |
Applicant | MEDTRONIC Inc. 8200 CORAL SEA STREET MS MVS11 MOUNDS VIEW, MN 55112 |
PMA Number | P980050 |
Supplement Number | S021 |
Date Received | 02/14/2006 |
Decision Date | 03/31/2006 |
Product Code |
LWS |
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 THE MEDTRONIC MODEL 9986 DESKTOP/BOSS (SOFTWARE VERSION 1.5.1) FOR THE MEDTRONIC MODEL 2090 CARELINK PROGRAMMER FOR ALL MEDTRONIC PACEMAKER AND ICD MODELS. IT IS TO ENHANCE INTERNAL |