|Trade Name||FOCAL CATHETERS|
|Classification Name||cardiac ablation percutaneous catheter|
|Applicant||MEDTRONIC CRYOCATH LP|
|Supplement Type||30-day notice|
|Supplement Reason|| process change: manufacturing|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Addition of an inspection procedure for the low pressure regulator during manufacturing, as well as the replacement of an analog pressure gauge used during installation and maintenance with a digital one.