|
Device | MEDTRONIC INSYNC ICD MODEL 7272 AND MODEL 9969 APPLICATION SOFTWARE |
Generic Name | Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D) |
Applicant | MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT 8200 CORAL SEA STREET N.E. MOUNDS VIEW, MN 55112 |
PMA Number | P010031 |
Supplement Number | S012 |
Date Received | 01/28/2004 |
Decision Date | 05/28/2004 |
Product Code |
NIK |
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 1) CHANGES TO THE INVESTIGATIONAL PLAN AND IMPLANT FORMS OF THE POST-APPROVAL STUDY AND 2) THE ADDITION OF THE INSYNC MODEL 7277 WITH MODEL 9983 APPLICATION SOFTWARE TO THE STUDY. |