Medtronic Deep Brain Stimulation Therapy System
FDA premarket approval P960009/S397 · decided 2021-05-07
Approval details
- PMA number
- P960009
- Supplement
- S397
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Medtronic Deep Brain Stimulation Therapy System
- Generic name
- Stimulator, electrical, implanted, for parkinsonian tremor
- Applicant
- Medtronic, Inc.
- Date received
- 2021-02-23
- Decision date
- 2021-05-07
- Days to decision
- 73 days
- Decision code
- APPR
- Product code
- MHY
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- Approval for software changes to the Medtronic Model A620 Patient Programmer Application (PPA)which consist of 1) fixing a defect that prevents the software from communicating with certain Model B35200 INSs that have Tel-M IDs containing particular values, 2) updating the impedance test that is used to support the MRI eligibility feature of the A620 PPA, and 3) other minor changes and bug fixes.
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