|
Device | INSYNC MARQUIS MODEL 7277LINSYNC II MARQUIS MODEL 7289; INSYNC III MARQUIS MODEL 7279,INSYNC II PROTECT MODEL 7295; UNSY |
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 | S053 |
Date Received | 10/10/2006 |
Decision Date | 11/15/2006 |
Product Code |
NIK |
Advisory Committee |
Cardiovascular |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR THE DESIGN CHANGE TO ADD ALTERNATE TANTALUM CAPACITOR (XTC018) ON THE HYBRID OF THE MEDTRONIC ICDS. |