PMA P010032S163
- Device
- Totally Implanted Spinal Cord Stimulator for Pain Relief
- Applicant
- ABBOTT MEDICAL
- PMA number
- P010032
- Supplement
- S163
- Product code
- LGW
- Decision date
- 2020-05-30
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Approval order statement
- Alternative bacterial endotoxin test method.
Current openFDA PMA Record#
- Device
- Totally Implanted Spinal Cord Stimulator for Pain Relief
- Applicant
- ABBOTT MEDICAL
- PMA number
- P010032
- Supplement
- S163
- Product code
- LGW
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Decision date
- 2020-05-30
- Decision code
- OK30
- Date received
- 2020-04-30
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Alternative bacterial endotoxin test method.