Activa Deep Brain Stimulation Therapy System, Percept PC BrainSense
FDA premarket approval P960009/S474 · decided 2024-07-01
Approval details
- PMA number
- P960009
- Supplement
- S474
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- Activa Deep Brain Stimulation Therapy System, Percept PC BrainSense
- Generic name
- Stimulator, electrical, implanted, for parkinsonian tremor
- Applicant
- Medtronic, Inc.
- Date received
- 2024-02-28
- Decision date
- 2024-07-01
- Days to decision
- 124 days
- Decision code
- APPR
- Product code
- MHY
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- which requested approval for the following changes for each supplement:For P960009/S474 for: The removal of the contraindication: Implantation of a deep brain stimulation system is contraindicated for patients for whom test stimulation is unsuccessful and the addition of a precaution that specifies two conditions under which full system implantation can occur (i.e., successful test stimulation, or confirmation of lead implantation to the targeted site via imaging.) An update to MRI labeling t
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510(k) clearances by this applicant
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|---|---|---|
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