PMA P140009S127
- Device
- Infinity™ Deep Brain Stimulation (DBS) System
- Applicant
- ABBOTT MEDICAL
- PMA number
- P140009
- Supplement
- S127
- Product code
- MHY
- Decision date
- 2025-12-23
- Classification
- Neurology
- Generic name
- Stimulator, electrical, implanted, for parkinsonian tremor
- Approval order statement
- to implement quality control testing changes for the neuromodulation devices manufactured in Arecibo, Puerto Rico
Current openFDA PMA Record#
- Device
- Infinity™ Deep Brain Stimulation (DBS) System
- Applicant
- ABBOTT MEDICAL
- PMA number
- P140009
- Supplement
- S127
- Product code
- MHY
- Generic name
- Stimulator, electrical, implanted, for parkinsonian tremor
- Decision date
- 2025-12-23
- Decision code
- OK30
- Date received
- 2025-11-26
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- to implement quality control testing changes for the neuromodulation devices manufactured in Arecibo, Puerto Rico