|
Device | MEDTRONIC ICD MODEL INSYNC 7272 SYSTEM |
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 | S073 |
Date Received | 07/12/2007 |
Decision Date | 09/13/2007 |
Product Code |
NIK |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | Yes |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL FOR A LABELING UPDATE TO ADD A CLINICAL SUMMARY FOR THE COMPLETED INSYNC ICD MODEL 171 POST-APPROVAL STUDY. |