|
Device | INSYNCII/ III PROTECT/INSYNC II/III MARQUIS/INSYNC SENTRY/MAXIMO/CONCERTO/MAXIMO II |
Applicant | MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT 8200 CORAL SEA STREET N.E. MOUNDS VIEW, MN 55112 |
PMA Number | P010031 |
Supplement Number | S121 |
Date Received | 09/17/2008 |
Decision Date | 10/10/2008 |
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 TO PERFORM WAFER SAW AND DIE VISUAL PROCESSING AT THE SUPPLIER. |