|
Device | OL1000/OL1000 SC/SPINALOGIC BONE GROWTH STIMULATORS |
Generic Name | Stimulator, bone growth, non-invasive |
Applicant | DJO, LLC 1430 DECISION STREET VISTA, CA 92081-8553 |
PMA Number | P910066 |
Supplement Number | S016 |
Date Received | 04/11/2001 |
Decision Date | 05/18/2001 |
Product Code |
LOF |
Advisory Committee |
Orthopedic |
Supplement Type | Real-Time Process |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL TO: 1)REFORMAT THE PATIENT MANUALS FOR THE OL 1000 AND OL 1000 SC BONE GROWTH STIMULATORS PER THE RECENT CDRH GUIDANCE ON MEDICAL DEVICE LABELING, 2) REFORMAT THE PATIENT MANUAL FOR THE SPINALOGIC(TM) BONE GROWTH STIMULATOR PER THE RECENT CDRH GUIDANCE ON MEDICAL DEVICE LABELING. |