|
Device | INSYNC CRT-D; CONCERTO & VARIOUS INSYNC FAMILY OF ICDS |
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 | S082 |
Date Received | 10/11/2007 |
Decision Date | 11/16/2007 |
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 ADDITION OF A PAPERLESS CHART RECORDER TO THE STERILIZATION OPERATIONS AT THE TOLOCHENAZ, SWITZERLAND MANUFACTURING FACILITY. |