PMA P850007S023

Device: PHYSIO-STIM BONE GROWTH STIMULATOR
Applicant: Orthofix, Inc.
PMA number: P850007
Supplement: S023
Product code: LOF
Decision date: 1998-08-14
Classification: Stimulator, Bone Growth, Non-invasive
Generic name: Stimulator, bone growth, non-invasive
Approval order statement: Approval for the elimination of daily shut down after three hours ofuse and a change int he overall device lock-up time from 270 days to 365 days.

Current openFDA PMA Record#

Device: PHYSIO-STIM BONE GROWTH STIMULATOR
Applicant: Orthofix, Inc.
PMA number: P850007
Supplement: S023
Product code: LOF
Generic name: Stimulator, bone growth, non-invasive
Decision date: 1998-08-14
Decision code: APPR
Date received: 1998-07-21
Supplement type: Real-Time Process
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: Approval for the elimination of daily shut down after three hours ofuse and a change int he overall device lock-up time from 270 days to 365 days.