|
Device | INSYNC/INSYNC MARQUIS II/III/INSYNC II/III PROTECT/INSYNC SENTRY/MAXIMO/CONCERTO/II CRT-D/MAXIMO II/CONSULTA CRT-D |
Applicant | MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT 8200 CORAL SEA STREET N.E. MOUNDS VIEW, MN 55112 |
PMA Number | P010031 |
Supplement Number | S165 |
Date Received | 09/08/2009 |
Decision Date | 10/08/2009 |
Advisory Committee |
Cardiovascular |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order Statement CHANGE IN LOCATION OF A STERILIZATION SYSTEM. |