|
Device | INSYNC FAMILIES OF ICDS/CONCERTO/MAXIMO II/CONSULTA FAMILIES OF CRT-DS |
Applicant | MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT 8200 CORAL SEA STREET N.E. MOUNDS VIEW, MN 55112 |
PMA Number | P010031 |
Supplement Number | S145 |
Date Received | 02/18/2009 |
Decision Date | 08/05/2009 |
Advisory Committee |
Cardiovascular |
Supplement Type | 135 Review Track For 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR CHANGING A STERILIZATION SPECIFICATION FOR FINISHED DEVICE MANUFACTURING. |