|
Device | INSYNC SENTRY/MAXIMO CRT-D/INSYNC II PROTECT & MARQUIS/CONCERTO ICD |
Applicant | MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT 8200 CORAL SEA STREET N.E. MOUNDS VIEW, MN 55112 |
PMA Number | P010031 |
Supplement Number | S136 |
Date Received | 11/26/2008 |
Decision Date | 12/24/2008 |
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 IN MANUFACTURING LOCATION OF THE CHIP RESISTORS. |