PMA P950035S007
- Device
- NEUROCONTROL FREEHAND SYSTEM
- Applicant
- Biocontrol Technology, Inc.
- PMA number
- P950035
- Supplement
- S007
- Product code
- GZC
- Decision date
- 2000-06-23
- Classification
- Stimulator, Neuromuscular, Implanted
- Generic name
- Stimulator, neuromuscular, implanted
- Approval order statement
- APPROVAL FOR THE DISTRIBUTION OF AN IMPLANT TESTER ACCESSORY WHICH IS USED IN FINAL DEVICE TESTING AT THE COMPLETION OF SURGERY.
Current openFDA PMA Record#
- Device
- NEUROCONTROL FREEHAND SYSTEM
- Applicant
- Biocontrol Technology, Inc.
- PMA number
- P950035
- Supplement
- S007
- Product code
- GZC
- Generic name
- Stimulator, neuromuscular, implanted
- Decision date
- 2000-06-23
- Decision code
- APPR
- Date received
- 2000-03-14
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR THE DISTRIBUTION OF AN IMPLANT TESTER ACCESSORY WHICH IS USED IN FINAL DEVICE TESTING AT THE COMPLETION OF SURGERY.