|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||CONSULTA CRT-D, MAXIMO II CRT-D, CONCERTO 11 CRT-D, CPMCERTP CRT-D|
|Generic Name||cardiac resynchronization therapy|
|Supplement Type||normal 180 day track no user fee|
|Supplement Reason|| location change: manufacturer|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for a manufacturing site located at plexus (hangzhou) co. , ltd. , in hangzhou, zhejiang, china.