PMA P960009S354
- Device
- Activa Deep Brain Stimulation Therapy System
- Applicant
- Medtronic, Inc.
- PMA number
- P960009
- Supplement
- S354
- Product code
- MHY
- Decision date
- 2019-08-14
- Classification
- Stimulator, Electrical, Implanted, For Parkinsonian Tremor
- Generic name
- Stimulator, electrical, implanted, for parkinsonian tremor
- Approval order statement
- Use of newer test instrumentation for testing the electrolyte material and for updates to the test method used for the testing.
Current openFDA PMA Record#
- Device
- Activa Deep Brain Stimulation Therapy System
- Applicant
- Medtronic, Inc.
- PMA number
- P960009
- Supplement
- S354
- Product code
- MHY
- Generic name
- Stimulator, electrical, implanted, for parkinsonian tremor
- Decision date
- 2019-08-14
- Decision code
- OK30
- Date received
- 2019-07-16
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Use of newer test instrumentation for testing the electrolyte material and for updates to the test method used for the testing.