|
Device | CONCERTO II. CONSULTA, MAXIMO II, PROTECTA, PROTECTA XT |
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 | S268 |
Date Received | 07/18/2011 |
Decision Date | 07/23/2012 |
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 |
Approval Order Statement APPROVAL FOR A CHANGE TO THE BURN-IN TESTING PROCESS FOR TANTALUM CAPACITORS. |