PMA P010032S053
- Device
- RAPID PROGRAMMER
- Applicant
- ABBOTT MEDICAL
- PMA number
- P010032
- Supplement
- S053
- Product code
- LGW
- Decision date
- 2012-07-31
- Classification
- Stimulator, Spinal-cord, Totally Implanted For Pain Relief
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Approval order statement
- APPROVAL FOR UPGRADING THE RAPID PROGRAMMER SOFTWARE USED IN THE GENESIS AND EON FAMILY NEUROMODULATION STIMULATORS FROM VERSION 3.3 (MODEL 3831 AND 3832) TO VERSION 3.4 (MODEL 3834).
Current openFDA PMA Record#
- Device
- RAPID PROGRAMMER
- Applicant
- ABBOTT MEDICAL
- PMA number
- P010032
- Supplement
- S053
- Product code
- LGW
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Decision date
- 2012-07-31
- Decision code
- APPR
- Date received
- 2012-06-01
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR UPGRADING THE RAPID PROGRAMMER SOFTWARE USED IN THE GENESIS AND EON FAMILY NEUROMODULATION STIMULATORS FROM VERSION 3.3 (MODEL 3831 AND 3832) TO VERSION 3.4 (MODEL 3834).