- Device
- Quattrode®; Octrode™; Penta™; Lamitrode™; Tripole™; TriCentrus™ Lead Extensions
- Applicant
- ABBOTT MEDICAL
- PMA number
- P010032
- Supplement
- S251
- Product code
- LGW
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Decision date
- 2026-09-18
- Decision code
- APPR
- Date received
- 2026-04-17
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- 1) optimization of the process parameter ranges of the injection molding equipment used in the manufacturing of the Bionate® 55D injection-molded portions at the stimulation and terminal ends of the Quattrode™; Octrode™; Penta™; Lamitrode™; Tripole™; and TriCentrus™ Leads and Lead Extensions at the Abbott manufacturing facility in Arecibo, Puerto Rico; and 2) qualification of a second injection molding machine of identical make, model, and configuration to the existing Nissei STX10 Machine at the Abbott manufacturing facility in Arecibo, Puerto Rico.