|Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.|
|Trade Name||BRAVA CRT-D, BRAVA QUAD CRT-D, CONCERTO 11 CRT-D, CONSULTA CRT-D, MAXIMO II CRT-D, PROTECTA XT CRT-D, PROTECTA XT CRT-D,|
|Classification Name||defibrillator, automatic implantable cardioverter, with cardiac resynchronization (crt-d)|
|Supplement Type||real-time process|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for a minor design tolerance change and associated inspection procedure changes for multipolar feedthrough insulators for selected implantable cardioverter defibrillators and cardiac resynchronization therapy-defibrillators.