|
Device | DIVA FAMILY, SELECTION AFM C-SERIES AND T-SERIES DEVICES |
Generic Name | Implantable cardioverter defibrillator (non-CRT) |
Applicant | MEDTRONIC Inc. 8200 CORAL SEA STREET MS MVS11 MOUNDS VIEW, MN 55112 |
PMA Number | P980050 |
Supplement Number | S073 |
Date Received | 04/04/2012 |
Decision Date | 04/25/2012 |
Product Code |
LWS |
Advisory Committee |
Cardiovascular |
Supplement Type | Real-Time Process |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR SOFTWARE UPDATES AND MINOR SOFTWARE ENHANCEMENTS TOMEDTRONIC MODEL 9986 DESKTOP/ BASELINE OPERATING SYSTEM SOFTWARE (BOSS) VERSION 2.6 FOR THE MEDTRONIC MODEL 2090 CARELINK PROGRAMMER. |