PMA P970003S182

Device: ASPIRESR GENERATOR -MODEL 106
Applicant: LivaNova USA, Inc.
PMA number: P970003
Supplement: S182
Product code: MUZ
Decision date: 2015-12-18
Classification: Stimulator, Autonomic Nerve, Implanted (depression)
Generic name: Stimulator, autonomic nerve, implanted (depression)
Approval order statement: APPROVAL FOR USING A 2-POSITION PRE-SURGICAL SURFACE ELECTROCARDIOGRAPH (ECG) ASSESSMENT PROCEDURE TO IDENTIFY IMPLANT LOCATION.

Current openFDA PMA Record#

Device: ASPIRESR GENERATOR -MODEL 106
Applicant: LivaNova USA, Inc.
PMA number: P970003
Supplement: S182
Product code: MUZ
Generic name: Stimulator, autonomic nerve, implanted (depression)
Decision date: 2015-12-18
Decision code: APPR
Date received: 2015-07-01
Supplement type: Normal 180 Day Track
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: APPROVAL FOR USING A 2-POSITION PRE-SURGICAL SURFACE ELECTROCARDIOGRAPH (ECG) ASSESSMENT PROCEDURE TO IDENTIFY IMPLANT LOCATION.