|
Device | MEDTRONIC CONSULTA CRT-D D224TRK, MAXIMO 2 CRT-D D284TRK, CONCERTO 2 D274TRK IMPLANTSBLE CARDIOVERTER DEFIBRILLATORS |
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 | S193 |
Date Received | 03/31/2010 |
Decision Date | 05/11/2010 |
Product Code |
NIK |
Advisory Committee |
Cardiovascular |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL FOR UPDATES MADE TO THE PROGRAMMER APPLICATION SOFTWARE MODEL 9995 AND THE CARELINK DEVICE DATA MANAGEMENT APPLICATION (DDMA) IN RESPONSE TO ADVERSE FIELD EVENTS. |