The following data is part of a premarket notification filed by Innovative Health, Llc. with the FDA for Reprocessed Intellamap Orion High Resolution Mapping Catheter.
|Device Name:||Reprocessed IntellaMap Orion High Resolution Mapping Catheter|
|Classification||Catheter, Electrode Recording, Or Probe, Electrode Recording|
|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|