|
Device | MARQUIS DR 7274; MARQUIS VR 7230B/7230X/723E; MAXIMO DR7278; MAXIMO VR 7232 |
Generic Name | Implantable cardioverter defibrillator (non-CRT) |
Applicant | MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT 8200 CORAL SEA STREET N.E. MS MVS11 MOUNDS VIEW, MN 55112 |
PMA Number | P980016 |
Supplement Number | S468 |
Date Received | 02/25/2014 |
Decision Date | 04/24/2014 |
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 SIX SOFTWARE DEVICE APPLICATIONS ON THE ENCOREPROGRAMMER MODEL 29901. |