PMA P960009S387
- Device
- Activa Deep Brain Stimulation Therapy System
- Applicant
- Medtronic, Inc.
- PMA number
- P960009
- Supplement
- S387
- Product code
- MHY
- Decision date
- 2020-11-12
- Generic name
- Stimulator, electrical, implanted, for parkinsonian tremor
- Approval order statement
- Reduction in nonviable air sampling to comply with ISO 14644:2015-1.
Current openFDA PMA Record#
- Device
- Activa Deep Brain Stimulation Therapy System
- Applicant
- Medtronic, Inc.
- PMA number
- P960009
- Supplement
- S387
- Product code
- MHY
- Generic name
- Stimulator, electrical, implanted, for parkinsonian tremor
- Decision date
- 2020-11-12
- Decision code
- OK30
- Date received
- 2020-10-15
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Reduction in nonviable air sampling to comply with ISO 14644:2015-1.