|
Device | INSYNC SENTRY & MAXIMO USED WITH SOFTWARE APPLICATION, MODELS 7297 AND 7299 |
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 | S076 |
Date Received | 08/14/2007 |
Decision Date | 10/04/2007 |
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 SOFTWARE AND RAM-WARE MAINTENANCE UPDATES AS WELL AS ASSOCIATED REFERENCE AND IMPLANT MANUAL UPDATES. |