PMA P010032S164
- Device
- Spinal Cord Stimulation (SCS)
- Applicant
- ABBOTT MEDICAL
- PMA number
- P010032
- Supplement
- S164
- Product code
- LGW
- Decision date
- 2020-06-04
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Approval order statement
- Addition of an alternate tier-3 supplier for ASTM Grade-l Titanium material used in the manufacture for implantable pulse generators.
Current openFDA PMA Record#
- Device
- Spinal Cord Stimulation (SCS)
- Applicant
- ABBOTT MEDICAL
- PMA number
- P010032
- Supplement
- S164
- Product code
- LGW
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Decision date
- 2020-06-04
- Decision code
- OK30
- Date received
- 2020-05-07
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Addition of an alternate tier-3 supplier for ASTM Grade-l Titanium material used in the manufacture for implantable pulse generators.