PMA P960009S369
- Device
- Activa Deep Brain Stimulation Therapy System
- Applicant
- Medtronic, Inc.
- PMA number
- P960009
- Supplement
- S369
- Product code
- MHY
- Decision date
- 2020-03-20
- Generic name
- Stimulator, electrical, implanted, for parkinsonian tremor
- Approval order statement
- Process change to transfer incoming inspection visual testing of adhesive components to another Medtronic facility.
Current openFDA PMA Record#
- Device
- Activa Deep Brain Stimulation Therapy System
- Applicant
- Medtronic, Inc.
- PMA number
- P960009
- Supplement
- S369
- Product code
- MHY
- Generic name
- Stimulator, electrical, implanted, for parkinsonian tremor
- Decision date
- 2020-03-20
- Decision code
- OK30
- Date received
- 2020-02-19
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Process change to transfer incoming inspection visual testing of adhesive components to another Medtronic facility.