|
Device | INSYNC FAMILY & CONCERTO CRT-ICDS |
Generic Name | Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D) |
Applicant | MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT 8200 CORAL SEA STREET N.E. MOUNDS VIEW, MN 55112 |
PMA Number | P010031 |
Supplement Number | S078 |
Date Received | 08/23/2007 |
Decision Date | 09/11/2007 |
Product Code |
NIK |
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. |