PMA P140009S126

Device: 8CH Infinity™ DBS Lead Kit, 30cm, 0.5, B; 8CH Infinity™ DBS Lead Kit, 30cm, 1.5, B; 8CH Infinity™ DBS Lead Kit, 40cm, 0
Applicant: ABBOTT MEDICAL
PMA number: P140009
Supplement: S126
Product code: MHY
Decision date: 2026-02-11
Classification: Neurology
Generic name: Stimulator, electrical, implanted, for parkinsonian tremor
Approval order statement: Introduction of the manufacturing aid and stabilizer phosphoric acid to the Bionate raw material (55D PCU, 55D IMG, and 75D)

Current openFDA PMA Record#

Device: 8CH Infinity™ DBS Lead Kit, 30cm, 0.5, B; 8CH Infinity™ DBS Lead Kit, 30cm, 1.5, B; 8CH Infinity™ DBS Lead Kit, 40cm, 0
Applicant: ABBOTT MEDICAL
PMA number: P140009
Supplement: S126
Product code: MHY
Generic name: Stimulator, electrical, implanted, for parkinsonian tremor
Decision date: 2026-02-11
Decision code: APPR
Date received: 2025-11-03
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Introduction of the manufacturing aid and stabilizer phosphoric acid to the Bionate raw material (55D PCU, 55D IMG, and 75D)