PMA P010032S074
- Device
- PROTEGE SYSTEM
- Applicant
- ABBOTT MEDICAL
- PMA number
- P010032
- Supplement
- S074
- Product code
- LGW
- Decision date
- 2014-03-21
- Classification
- Stimulator, Spinal-cord, Totally Implanted For Pain Relief
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Approval order statement
- APPROVAL FOR LABELING MODIFICATIONS TO CHANGE THE NAME OF THE EON MINI IPG TO PROTÉGÉ (MODEL 3789); LABELING MODIFICATIONS TO CHANGE THE NAME OF THE EON MINI LE CHARGE TO PRODIGY CHARGER (MODEL 3730); AND MINOR SOFTWARE MODIFICATIONS TO THE PATIENT PROGRAMMER AND RAPID PROGRAMMER (MODEL 3852) TO RECOGNIZE THE DEVICE WITH THE NEW PROTÉGÉ DEVICE NAME AND MODEL NUMBER.
Current openFDA PMA Record#
- Device
- PROTEGE SYSTEM
- Applicant
- ABBOTT MEDICAL
- PMA number
- P010032
- Supplement
- S074
- Product code
- LGW
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Decision date
- 2014-03-21
- Decision code
- APPR
- Date received
- 2013-12-23
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR LABELING MODIFICATIONS TO CHANGE THE NAME OF THE EON MINI IPG TO PROTÉGÉ (MODEL 3789); LABELING MODIFICATIONS TO CHANGE THE NAME OF THE EON MINI LE CHARGE TO PRODIGY CHARGER (MODEL 3730); AND MINOR SOFTWARE MODIFICATIONS TO THE PATIENT PROGRAMMER AND RAPID PROGRAMMER (MODEL 3852) TO RECOGNIZE THE DEVICE WITH THE NEW PROTÉGÉ DEVICE NAME AND MODEL NUMBER.