|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||TAPSCOPE 550|
|Classification Name||system, esophageal pacing|
|Generic Name||esophageal pacing system|
|Supplement Type||135 review track for 30-day notice|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval of a new supplier for the molding of the pacing wire connector and revision to the manufacturing process of the pacing wire assembly.