PMA P910066S015

Device: SPINALOGIC BONE GROWTH STIMULATOR
Applicant: Djo, LLC
PMA number: P910066
Supplement: S015
Product code: LOF
Decision date: 2000-08-23
Classification: Stimulator, Bone Growth, Non-invasive
Generic name: Stimulator, bone growth, non-invasive
Approval order statement: APPROVAL TO *REMOVE THE FOLLOWING PRECAUTION FROM THE SUMMARY OF SAFETY AND EFFECTIVENESS AND PROFESSIONAL LABELING; "THE SAFETY AND EFFECTIVENESS OF THE SPINALOGIC(R) HAS ONLY BEEN STUDIED IN PATIENTS HAVING SPINAL FUSION TREATMENT. THE SAFETY AND EFFECTIVENESS OF THIS DEVICE IN PATIENTS RECEIVING INSTRUMENTATION, WHICH MAY DISTORT THE MAGNETIC FIELD GENERATED BY THE DEVICE AND THUS PRODUCE A LESS EFFECTIVE TREATMENT, HAS NOT BEEN ESTABLISHED"; AND *MODIFY THE FOLLOWING STATEMENT I NTHE RISKS AND BENEFITS SECTION OF THE PATIENT LABELING FROM: "THE SAFETY AND BENEFIT OF THE SPINALOGIC(R) WAS NOT STUDIED FOR PATIENTS WHO ALSO HAVE METAL IMPLANTS AT THE SPOT OF THEIR BACK SURGERY," TO "THE SPINALOGIC(R) WAS NOT STUDIED FOR PATIENTS WHO ALSO HAVE METAL IMPLANTS AT THE SPOT OF THEIR BACK SURGERY."

Current openFDA PMA Record#

Device: SPINALOGIC BONE GROWTH STIMULATOR
Applicant: Djo, LLC
PMA number: P910066
Supplement: S015
Product code: LOF
Generic name: Stimulator, bone growth, non-invasive
Decision date: 2000-08-23
Decision code: APPR
Date received: 2000-03-31
Supplement type: Real-Time Process
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: APPROVAL TO *REMOVE THE FOLLOWING PRECAUTION FROM THE SUMMARY OF SAFETY AND EFFECTIVENESS AND PROFESSIONAL LABELING; "THE SAFETY AND EFFECTIVENESS OF THE SPINALOGIC(R) HAS ONLY BEEN STUDIED IN PATIENTS HAVING SPINAL FUSION TREATMENT. THE SAFETY AND EFFECTIVENESS OF THIS DEVICE IN PATIENTS RECEIVING INSTRUMENTATION, WHICH MAY DISTORT THE MAGNETIC FIELD GENERATED BY THE DEVICE AND THUS PRODUCE A LESS EFFECTIVE TREATMENT, HAS NOT BEEN ESTABLISHED"; AND *MODIFY THE FOLLOWING STATEMENT I NTHE RISKS AND BENEFITS SECTION OF THE PATIENT LABELING FROM: "THE SAFETY AND BENEFIT OF THE SPINALOGIC(R) WAS NOT STUDIED FOR PATIENTS WHO ALSO HAVE METAL IMPLANTS AT THE SPOT OF THEIR BACK SURGERY," TO "THE SPINALOGIC(R) WAS NOT STUDIED FOR PATIENTS WHO ALSO HAVE METAL IMPLANTS AT THE SPOT OF THEIR BACK SURGERY."