Quattrode®; Octrode; Penta; Lamitrode; Tripole; TriCentrus Lead Extensions
ABBOTT MEDICAL · Stimulator, spinal-cord, totally implanted for pain relief · Neurology
Open FDA's page for this record- PMA number
- P010032
- Supplement number
- S251
- Applicant
- ABBOTT MEDICAL
- Street 1
- 6901 Preston Rd.
- City
- Plano
- State
- TX
- Zip
- 75024
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Trade name
- Quattrode®; Octrode; Penta; Lamitrode; Tripole; TriCentrus Lead Extensions
- Product code
- LGW
- Advisory committee
- NE
- Advisory committee description
- Neurology
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Expedited review flag
- N
- Date received
- 2026-04-17
- Decision date
- 2026-09-18
- Decision code
- APPR
- Ao 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.
- Harmonized identifiers (openFDA)
- Device name
- Stimulator, Spinal-Cord, Totally Implanted For Pain Relief
- Medical specialty description
- Unknown
- Device class
- 3
- Registration number
- 3010966701, 3006630150, 9610139, 3019807891, 3013973539, 3009380063, 3003335547, 3016618265, 3004209178, 1627487, 3004519921, 2024311, 3004593495, 9616693, 2182291, 2124215, 2133772, 2135338, 3005160949, 3018094310, 3007882731, 3005210579, 3020969413, 2134604, 2183744, 3021836309, 2649622, 1035166, 3003477135, 2133810, 3038429246, 3027063190, 3008988055, 3012693387, 1928237, 3006705815, 3015173212, 3003120897, 3010086866, 3010326622 +15 more
- FEI number
- 3010966701, 3006630150, 3000209794, 3019807891, 3013973539, 3009380063, 3003335547, 3016618265, 1627487, 3005700659, 2024311, 3004593495, 2182291, 3002623849, 2124215, 3000203066, 3005160949, 3007882731, 3005210579, 3020969413, 3004369318, 3002806500, 2183744, 3021836309, 2649622, 1035166, 3003477135, 3038429246, 3027063190, 3008988055, 3012693387, 1928237, 3006705815, 3015173212, 3003120897, 3010086866, 3010326622, 3000206435, 3013023969, 2648729 +15 more