|
Device | MEDTRONIC VISION SOFTWARE SERIES 4.0 |
Generic Name | Implantable cardioverter defibrillator (non-CRT) |
Applicant | MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT 8200 CORAL SEA STREET N.E. MOUNDS VIEW, MN 55112 |
PMA Number | P900061 |
Supplement Number | S043 |
Date Received | 02/22/2001 |
Decision Date | 03/15/2001 |
Product Code |
LWS |
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 PROGRAMMING SOFTWARE TO BE USED WITH THE MEDTRONIC GEM (MODEL 9962 SOFTWARE) ICD SYSTEM. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME OF MEDTRONIC VISION SOFTWARE SERIES 4.0. |