|
Device | INSYNC MAQUIS, INSYNC MAXIMO, INSYNC SENTRY AND IMSYNC II MARQUIS IMPLANTABLE DEVICES |
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 | S035 |
Date Received | 02/01/2006 |
Decision Date | 02/28/2006 |
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 ELECTRICAL SAFETY INSTRUCTIONS FOR THE CARELINK MONITOR. |