PMA P120024S002

Device: ACTIVL ARTIFICIAL DISC
Applicant: Highridge Medical, LLC
PMA number: P120024
Supplement: S002
Product code: MJO
Decision date: 2015-11-04
Classification: Prosthesis, Intervertebral Disc
Generic name: Prosthesis, intervertebral disc
Approval order statement: APPROVAL FOR CHANGES TO THE ACTIVL® ARTIFICIAL DISC LABELING THAT PROPOSED CHANGES TO THE INSTRUCTIONS FOR USE, SURGICAL TECHNIQUE, PATIENT BROCHURE, AND PACKAGE LABEL TO REFLECT THE MR TESTING THAT WAS CONDUCTED.

Current openFDA PMA Record#

Device: ACTIVL ARTIFICIAL DISC
Applicant: Highridge Medical, LLC
PMA number: P120024
Supplement: S002
Product code: MJO
Generic name: Prosthesis, intervertebral disc
Decision date: 2015-11-04
Decision code: APPR
Date received: 2015-08-07
Supplement type: Real-Time Process
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: APPROVAL FOR CHANGES TO THE ACTIVL® ARTIFICIAL DISC LABELING THAT PROPOSED CHANGES TO THE INSTRUCTIONS FOR USE, SURGICAL TECHNIQUE, PATIENT BROCHURE, AND PACKAGE LABEL TO REFLECT THE MR TESTING THAT WAS CONDUCTED.