|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||PARADYM RF CRT-D|
|Classification Name||defibrillator, automatic implantable cardioverter, with cardiac resynchronization (crt-d)|
|Applicant||SORIN GROUP- CRM|
|Supplement Type||30-day notice|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Changes for the devices (platform zl102): 1) added equipment cooler stacker/de-stacker used in the electronic smd assembly line; 2) laser welding process rework for visual defect on case; and 3. Paradym rf (zl102), in sourcing of rf module manufacturing.