PMA P140009S128
- Device
- Deep Brain Stimulation (DBS) Implantable Pulse Generator (IPG)
- Applicant
- ABBOTT MEDICAL
- PMA number
- P140009
- Supplement
- S128
- Product code
- MHY
- Decision date
- 2026-02-10
- Classification
- Neurology
- Generic name
- Stimulator, electrical, implanted, for parkinsonian tremor
- Approval order statement
- requested approval to implement process and equipment changes at a second-tier supplier
Current openFDA PMA Record#
- Device
- Deep Brain Stimulation (DBS) Implantable Pulse Generator (IPG)
- Applicant
- ABBOTT MEDICAL
- PMA number
- P140009
- Supplement
- S128
- Product code
- MHY
- Generic name
- Stimulator, electrical, implanted, for parkinsonian tremor
- Decision date
- 2026-02-10
- Decision code
- OK30
- Date received
- 2026-01-13
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- requested approval to implement process and equipment changes at a second-tier supplier