PMA P850007S020

Device: PHYSIO STIM AND PHYSIO STIM LITE BONE GROWTH STIMULATORS
Applicant: Orthofix, Inc.
PMA number: P850007
Supplement: S020
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 to modify the device labeling to include Patient Registry data in addition to the original data contained in the PMA

Current openFDA PMA Record#

Device: PHYSIO STIM AND PHYSIO STIM LITE BONE GROWTH STIMULATORS
Applicant: Orthofix, Inc.
PMA number: P850007
Supplement: S020
Product code: LOF
Generic name: Stimulator, bone growth, non-invasive
Decision date: 2000-03-09
Decision code: APPR
Date received: 1997-08-25
Supplement type: Normal 180 Day Track
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: Approval to modify the device labeling to include Patient Registry data in addition to the original data contained in the PMA