|
Device | MEDTRONIC MODEL 7219C/7202C JEWEL ACTIVE CAN MANAGEMENT SYSTEMS |
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 | S014 |
Date Received | 07/03/1995 |
Decision Date | 12/06/1995 |
Product Code |
LWS |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR THE MEDTRONIC MODEL 7219C/7202C JEWEL ACTIVE CAN ARRHYTHMIA MANAGEMENT SYSTEMS. THE MODEL 7220C WAS WITHDRAWN FROM THE REFERENCED APPLICATION, AND THEREFORE APPROVAL IS NOT GRANTED FOR THAT MODEL |