PMA P850007S030
- Device
- PHYSIO-STIM/SPINAL-STIM
- Applicant
- Orthofix, Inc.
- PMA number
- P850007
- Supplement
- S030
- Product code
- LOF
- Decision date
- 2011-01-12
- Classification
- Stimulator, Bone Growth, Non-invasive
- Generic name
- Stimulator, bone growth, non-invasive
- Approval order statement
- APPROVAL FOR A MANUFACTURING SITE LOCATED IN LEWISVILLE, TEXAS.
Current openFDA PMA Record#
- Device
- PHYSIO-STIM/SPINAL-STIM
- Applicant
- Orthofix, Inc.
- PMA number
- P850007
- Supplement
- S030
- Product code
- LOF
- Generic name
- Stimulator, bone growth, non-invasive
- Decision date
- 2011-01-12
- Decision code
- APPR
- Date received
- 2010-01-21
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR A MANUFACTURING SITE LOCATED IN LEWISVILLE, TEXAS.