|
Device | MEDTRONIC PCD TACHYARRHYTHMIA CONTROL SYSTEM |
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 | S066 |
Date Received | 06/28/2006 |
Decision Date | 07/12/2006 |
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 THE ADDITION OF THE PRESCRIPTION LABEL INADVERTENTLY OMITTED FROM THE MANUALS FOR THE MEDTRONIC MODEL 5719 ACTIVE CAN EMULATOR (ACE) AND THE MODEL 5460 ACE HEADER. |