PMA P960009S535
- Device
- Activa™ Deep Brain Stimulation Therapy System; Percept™ PC BrainSense™ (3387S, 3389S, 3550-05, B31010)
- Applicant
- Medtronic, Inc.
- PMA number
- P960009
- Supplement
- S535
- Product code
- MHY
- Decision date
- 2026-05-22
- Classification
- Neurology
- Generic name
- Stimulator, electrical, implanted, for parkinsonian tremor
- Approval order statement
- approval for an alternate Tip Tunneling Guide manufacturer
Current openFDA PMA Record#
- Device
- Activa™ Deep Brain Stimulation Therapy System; Percept™ PC BrainSense™ (3387S, 3389S, 3550-05, B31010)
- Applicant
- Medtronic, Inc.
- PMA number
- P960009
- Supplement
- S535
- Product code
- MHY
- Generic name
- Stimulator, electrical, implanted, for parkinsonian tremor
- Decision date
- 2026-05-22
- Decision code
- OK30
- Date received
- 2026-04-24
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- approval for an alternate Tip Tunneling Guide manufacturer