PMA P960009S381
- Device
- Percept Deep Brain Stimulation Therapy System
- Applicant
- Medtronic, Inc.
- PMA number
- P960009
- Supplement
- S381
- Product code
- MHY
- Decision date
- 2020-09-11
- Generic name
- Stimulator, electrical, implanted, for parkinsonian tremor
- Approval order statement
- Tightening of material controls of fluorinated carbon (CFx) material received from the external supplier.
Current openFDA PMA Record#
- Device
- Percept Deep Brain Stimulation Therapy System
- Applicant
- Medtronic, Inc.
- PMA number
- P960009
- Supplement
- S381
- Product code
- MHY
- Generic name
- Stimulator, electrical, implanted, for parkinsonian tremor
- Decision date
- 2020-09-11
- Decision code
- OK30
- Date received
- 2020-08-12
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Tightening of material controls of fluorinated carbon (CFx) material received from the external supplier.