|
Device | MEDTRONIC GEM III AT WITH APP DEVICE MODEL 7276 AND SOFTWARE MODEL9974 |
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 | S024 |
Date Received | 06/12/2006 |
Decision Date | 09/13/2006 |
Product Code |
LWS |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Postapproval Study Protocol |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR MODIFICATIONS TO THE POST APPROVAL STUDY TO UPDATE THE RESPECT STUDY PROTOCOL AND RELATED DOCUMENTATION TO INCORPORATE THE ENRHYTHM DEVICE (MODEL P15001DR), THE ENRHYTHM SOFTWARE (MODEL 9987), AND THE INCHECK PATIENT ASSISTANT (MODEL 2696). |