PMA P850007S034
- Device
- PHYSIO-STIM AND SPINAL-STIM
- Applicant
- Orthofix, Inc.
- PMA number
- P850007
- Supplement
- S034
- Product code
- LOF
- Decision date
- 2015-08-26
- Classification
- Stimulator, Bone Growth, Non-invasive
- Generic name
- Stimulator, bone growth, non-invasive
- Approval order statement
- IMPLEMENTATION OF AN ALTERNATE MACHINE TO PRODUCE TRANSDUCER COILS (CERVICAL-STIM ONLY) AND REMOVE REDUNDANT INSPECTION OF VARIOUS DEVICE COMPONENTS.
Current openFDA PMA Record#
- Device
- PHYSIO-STIM AND SPINAL-STIM
- Applicant
- Orthofix, Inc.
- PMA number
- P850007
- Supplement
- S034
- Product code
- LOF
- Generic name
- Stimulator, bone growth, non-invasive
- Decision date
- 2015-08-26
- Decision code
- OK30
- Date received
- 2015-07-28
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- IMPLEMENTATION OF AN ALTERNATE MACHINE TO PRODUCE TRANSDUCER COILS (CERVICAL-STIM ONLY) AND REMOVE REDUNDANT INSPECTION OF VARIOUS DEVICE COMPONENTS.