|
Device | INSYNC II PROTECT/INSYNC SENTRY/INSYNC MAXIMO/INSYNC MARQUIS ICDS |
Applicant | MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT 8200 CORAL SEA STREET N.E. MOUNDS VIEW, MN 55112 |
PMA Number | P010031 |
Supplement Number | S144 |
Date Received | 02/13/2009 |
Decision Date | 10/01/2009 |
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 |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL FOR REPLACING OBSOLETE EQUIPMENT WITH NEW EQUIPMENT. |