|
Device | GEM III AT |
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 | S076 |
Date Received | 08/07/2012 |
Decision Date | 10/26/2012 |
Product Code |
LWS |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Review Memo | Review Memo |
Approval Order Statement APPROVAL FOR THE MEDTRONIC ICD LONGEVITY ESTIMATION TOOL (MILET) TO BE USED BY MEDTRONIC PERSONNEL FOR THE DEVICES. |
Approval Order | Approval Order |