|
Device | INSYNC FAMILIES OF CRT-ICD'S |
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 | S038 |
Date Received | 02/21/2006 |
Decision Date | 04/21/2006 |
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 SESSIONSYNC FEATURE AS PART OF AN ENHANCEMENT TO MODEL 9986 DESKTOP / BASELINE OPERATING SYSTEM SOFTWARE (BOSS) VERSIONS 1.3.8/1.5 FOR THE 2090 CARELINK PROGRAMMER. SESSIONSYNC ALLOWS DATA TRANSFER BETWEEN THE MODEL 2090 CARELINK PROGRAMMER AND THE CUSTOMER'S PACEART SYSTEM (A DATA MANAGEMENT SYSTEM). |