|
Device | CONSULTA CRT-D/MAXIMO II CRT-D/CONCERTO II CRT-D |
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 | S169 |
Date Received | 10/08/2009 |
Decision Date | 01/13/2010 |
Product Code |
NIK |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Location Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL FOR A MANUFACTURING SITE LOCATED AT MEDTRONIC SWISS MANUFACTURING OPERATIONS IN TOLOCHENAZ, SWITZERLAND TO PERFORM FINAL PACKAGING FOR THE DEVICE. |