|
Device | MODEL 9896 SOFTWARE FOR THE JEWEL MODEL 7218 |
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 | S052 |
Date Received | 05/30/2002 |
Decision Date | 06/12/2002 |
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 MEDTRONIC MODEL 9896 SOFTWARE FOR USE WITH THE MEDTRONIC MODEL 2090 PROGRAMMER SERIES FOR USE IN PROGRAMMING THE JEWEL MODEL 7218. |