PMA P010032S143
- Device
- Spinal Cord Stimulation (SCS) Leads, Extensions and Adapters
- Applicant
- ABBOTT MEDICAL
- PMA number
- P010032
- Supplement
- S143
- Product code
- LGW
- Decision date
- 2018-10-03
- Classification
- Stimulator, Spinal-cord, Totally Implanted For Pain Relief
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Approval order statement
- Manufacturing process change that incorporates an automatic test method to measure the inner and outer SCS and DBS tubing.
Current openFDA PMA Record#
- Device
- Spinal Cord Stimulation (SCS) Leads, Extensions and Adapters
- Applicant
- ABBOTT MEDICAL
- PMA number
- P010032
- Supplement
- S143
- Product code
- LGW
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Decision date
- 2018-10-03
- Decision code
- OK30
- Date received
- 2018-09-06
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Manufacturing process change that incorporates an automatic test method to measure the inner and outer SCS and DBS tubing.