PMA P910066S014
- Device
- ORTHOLOGIC 1000-SC BONE GROWTH STIMULATOR
- Applicant
- Djo, LLC
- PMA number
- P910066
- Supplement
- S014
- Product code
- LOF
- Decision date
- 2000-03-09
- Classification
- Stimulator, Bone Growth, Non-invasive
- Generic name
- Stimulator, bone growth, non-invasive
- Approval order statement
- Approval for revisions to the Physician Manual and Package Insert, and the Patient Manual.
Current openFDA PMA Record#
- Device
- ORTHOLOGIC 1000-SC BONE GROWTH STIMULATOR
- Applicant
- Djo, LLC
- PMA number
- P910066
- Supplement
- S014
- Product code
- LOF
- Generic name
- Stimulator, bone growth, non-invasive
- Decision date
- 2000-03-09
- Decision code
- APPR
- Date received
- 2000-02-15
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for revisions to the Physician Manual and Package Insert, and the Patient Manual.