|
Device | MODEL 2490G/H/J MEDTRONIC CARELINK MONITOR AND THE MODEL 2020A CARDIOSIGHT READER |
Generic Name | Implantable cardioverter defibrillator (non-CRT) |
Applicant | MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT 8200 CORAL SEA STREET N.E. MOUNDS VIEW, MN 55112 |
PMA Number | P900061 |
Supplement Number | S073 |
Date Received | 08/23/2007 |
Decision Date | 09/11/2007 |
Product Code |
LWS |
Advisory Committee |
Cardiovascular |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR LABELING CHANGES THAT ADD AN INSTRUCTION THAT IS INTENDED TO ENHANCE THE SAFE USE OF THE DEVICE.APPROVAL FOR LABELING CHANGES THAT ADD AN INSTRUCTION THAT IS INTENDED TO ENHANCE THE SAFE USE OF THE DEVICE. |