- Device
- Activa Deep Brain Stimulation Therapy System, Percept PC BrainSense
- Applicant
- Medtronic, Inc.
- PMA number
- P960009
- Supplement
- S406
- Product code
- MHY
- Generic name
- Stimulator, electrical, implanted, for parkinsonian tremor
- Decision date
- 2021-09-01
- Decision code
- OK30
- Date received
- 2021-08-03
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Equipment updates in the CEA 2-3 Silicone Molding area (e.g., six additional ovens), updated option for use of temperature recorder (Vaisala Monitoring System Model VL-1700-54T), updated oven mode for the new ovens to use Manual Mode, removal of monitor lot for all ovens, removal of setup lot of new ovens, addition of a new and smaller basket for oven use, and addition of a new toolmaker scope (Nikon MM-40); 2) an update to the applicable work instructions (WI); and 3) the oven operation of allowing the new ovens to be opened during the middle of a run to add or remove lots from the oven and FACTORYworks (FW) updates to support the changes.