PMA P910066S002

Device: ORTHOLOGIC (TM)1000 BONE GROWTH STIMULATOR
Applicant: Djo, LLC
PMA number: P910066
Supplement: S002
Product code: LOF
Decision date: 1997-01-03
Classification: Stimulator, Bone Growth, Non-invasive
Generic name: Stimulator, bone growth, non-invasive
Approval order statement: APPROVAL FOR A LABELING CHANGE FOR THE DEVICE TO REFERENCE THE RESULTS OF AN EXPANDED PATIENT DATA REGISTRY FOR PATIENTS TREATED WITH THE DEVICE DURING THE FIRST TWO YEARS OF MARKETING FOR THE APPROVED INDICATION.

Current openFDA PMA Record#

Device: ORTHOLOGIC (TM)1000 BONE GROWTH STIMULATOR
Applicant: Djo, LLC
PMA number: P910066
Supplement: S002
Product code: LOF
Generic name: Stimulator, bone growth, non-invasive
Decision date: 1997-01-03
Decision code: APPR
Date received: 1996-02-20
Supplement type: Normal 180 Day Track
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: APPROVAL FOR A LABELING CHANGE FOR THE DEVICE TO REFERENCE THE RESULTS OF AN EXPANDED PATIENT DATA REGISTRY FOR PATIENTS TREATED WITH THE DEVICE DURING THE FIRST TWO YEARS OF MARKETING FOR THE APPROVED INDICATION.