Activa Deep Brain Stimulation Therapy Systems
FDA premarket approval P960009/S378 · decided 2020-08-12
Approval details
- PMA number
- P960009
- Supplement
- S378
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- Activa Deep Brain Stimulation Therapy Systems
- Generic name
- Stimulator, electrical, implanted, for parkinsonian tremor
- Applicant
- Medtronic, Inc.
- Date received
- 2020-08-04
- Decision date
- 2020-08-12
- Days to decision
- 8 days
- Decision code
- APPR
- Product code
- MHY
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- Approval of Changes being Effected (CBE) for the enhancement and harmonization of the physician and patient labeling to include precaution statements regarding risks of loss of coordination during activities requiring coordination (e.g. swimming) and bathing in the labeling across the device type.
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