|
Device | CONCERTO/II/CONSULTA/INSYNC ICD/INSYNC MARQUIS/MAXIMO/INSYNC II MARQUIS/MAXIMO II/INSYNC II PROTECT/III MARQUIS/SENTRY |
Generic Name | Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D) |
Applicant | MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT 8200 CORAL SEA STREET N.E. MOUNDS VIEW, MN 55112 |
PMA Number | P010031 |
Supplement Number | S206 |
Date Received | 06/28/2010 |
Decision Date | 11/10/2010 |
Product Code |
NIK |
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 IMPLEMENTATION OF A NEW RELEASE OF TRACEABILITY SOFTWARE. |