The following data is part of a premarket notification filed by Atrility Medical, Llc with the FDA for Atriamp, Atriamp - Pacing Cable Medtronic Connector, Atriamp - Pacing Cable Oscor Connector.
|Device Name:||AtriAmp, AtriAmp - Pacing Cable Medtronic Connector, AtriAmp - Pacing Cable Oscor Connector|
|Classification||Cable, Transducer And Electrode, Patient, (including Connector)|
|Applicant||Atrility Medical, LLC 313 Price Place, Suite 13 Madison, WI 53705|
Quality & Regulatory Associates, LLC 800 Levanger Lane Stoughton, WI 53589
|CFR Regulation Number||870.2900 [🔎]|
|Decision||Substantially Equivalent (SESE)|
|3rd Party Reviewed||No|