|
Device | INSYNC FAMILIES OF CRT-ICD'S |
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 | S056 |
Date Received | 10/30/2006 |
Decision Date | 11/29/2006 |
Product Code |
NIK |
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 THE MCI UPGRADE TO INCLUDE THE BRADY ENHANCEMENTS. |