- Device
- Deep Brain Stimulation (DBS) Implantable Pulse Generator (IPG)
- Applicant
- ABBOTT MEDICAL
- PMA number
- P140009
- Supplement
- S130
- Product code
- MHY
- Generic name
- Stimulator, electrical, implanted, for parkinsonian tremor
- Decision date
- 2026-04-25
- Decision code
- APPR
- Date received
- 2026-03-27
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- incorporate an additional inspection step to provide enhanced assurance of device reliability and safety; this change adds a manufacturing functional test to verify Bluetooth Low Energy (BLE) communication functionality of devices prior to distribution