PMA P010032S146
- Device
- Spinal Cord Stimulation (SCS) Leads, Extensions and Adapters
- Applicant
- ABBOTT MEDICAL
- PMA number
- P010032
- Supplement
- S146
- Product code
- LGW
- Decision date
- 2019-01-16
- Classification
- Stimulator, Spinal-cord, Totally Implanted For Pain Relief
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Approval order statement
- Addition of alternate biological indicator testing sites at Plymouth, Minnesota and Plano, Texas; and a change in release time of ambient aeration.
Current openFDA PMA Record#
- Device
- Spinal Cord Stimulation (SCS) Leads, Extensions and Adapters
- Applicant
- ABBOTT MEDICAL
- PMA number
- P010032
- Supplement
- S146
- Product code
- LGW
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Decision date
- 2019-01-16
- Decision code
- OK30
- Date received
- 2018-12-17
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Addition of alternate biological indicator testing sites at Plymouth, Minnesota and Plano, Texas; and a change in release time of ambient aeration.