|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 USA INC.|
|Supplement Type||30-day notice|
|Expedited Review Granted?|| No|
|Approval Order Statement |
The following changes: 1) an alternate reflow oven with an updated reflow soldering profile and an alternate component carrier; 2) an update to the rework process; 3) in-sourcing of an electronic assembly; 4) clean room layout modification at saluggia, italy, plant, and; 5)an alternate method for a hybrid module wire bonding process.