|
Device | ORTHOLOGIC (TM)1000 BONE GROWTH STIMULATOR |
Generic Name | Stimulator, bone growth, non-invasive |
Applicant | DJO, LLC 1430 DECISION STREET VISTA, CA 92081-8553 |
PMA Number | P910066 |
Supplement Number | S002 |
Date Received | 02/20/1996 |
Decision Date | 01/03/1997 |
Product Code |
LOF |
Advisory Committee |
Orthopedic |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
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. |