The following data is part of a premarket notification filed by Innovative Health, Llc. with the FDA for Reprocessed Advisor Hd Grid Mapping Catheter, Sensor Enabled.
|Device Name:||Reprocessed Advisor HD Grid Mapping Catheter, Sensor Enabled|
|Classification||Catheter, Intracardiac Mapping, High-density Array|
|Applicant||Innovative Health, LLC. 1435 North Hayden Road, Suite 100 Scottsdale, AZ 85257|
Innovative Health, LLC. 1435 North Hayden Road, Suite 100 Scottsdale, AZ 85257
|CFR Regulation Number||870.1220 [🔎]|
|Decision||Substantially Equivalent (SESE)|
|3rd Party Reviewed||No|