|
Device | VARIOUS FAMILIES OF INSYNC CRT ICDS & CONCERTO CRT-ICD |
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 | S071 |
Date Received | 05/31/2007 |
Decision Date | 06/29/2007 |
Product Code |
NIK |
Advisory Committee |
Cardiovascular |
Supplement Type | 30-day notice |
Supplement Reason | process change - manufacturer/sterilizer/packager/supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement CHANGE IN VENDOR FOR THE 11V AND 22V ZENER DIODES USED IN THE HYBRID OF IMPLANTABLE CARDIOVERTER DEFIBRILLATORS AND CARDIAC RESYNCHRONIZATION THERAPY DEVICES. |