PHYSIO-STIM LITE BONE GROWTH STIMULATOR
FDA premarket approval P850007/S018 · decided 1997-04-16
Approval details
- PMA number
- P850007
- Supplement
- S018
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- PHYSIO-STIM LITE BONE GROWTH STIMULATOR
- Generic name
- Stimulator, bone growth, non-invasive
- Applicant
- Orthofix, Inc.
- Date received
- 1996-05-07
- Decision date
- 1997-04-16
- Days to decision
- 344 days
- Decision code
- APPR
- Product code
- LOF
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Lewisville, TX
- Statement
- APPROVAL FOR MODIFICATIONS TO THE DESIGN AND LABELING OF THE PHYSIO-STIM(R) BONE GROWTH STIMULATOR. THE DEVICE, AS MODIFIED, IS TO BE MARKETED UNDER THE TRADE NAME PHYSIO-STIM(R) LITE AND IS INDICATED FOR THE TREATMENT OF AN ESTABLISHED NONUNION ACQUIRED SECONDARY TO TRAUMA, EXCLUDING BERTEBRAE AND ALL FLAT BONES, WHERE THE WIDTH OF THE NONUNION DEFECT IS LESS THAN ONE-HALF THE WIDTH OF THE BONE TO BE TREATED. A NONUNION IS CONSIDERED TO BE ESTABLISHED WHEN A MINIMUM OF NINE MONTHS HAS ELAPSED S
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.