ACTIVA TREMOR CONTROL SYSTEM
FDA premarket approval P960009/S010 · decided 2000-04-12
Approval details
- PMA number
- P960009
- Supplement
- S010
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- ACTIVA TREMOR CONTROL SYSTEM
- Generic name
- Stimulator, electrical, implanted, for parkinsonian tremor
- Applicant
- Medtronic, Inc.
- Date received
- 2000-02-22
- Decision date
- 2000-04-12
- Days to decision
- 50 days
- Decision code
- APPR
- Product code
- MHY
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- Approval for the Model 7482 Extension, Connector Boot, and Extension Passer Tunneling System, for use in conjunction with the existing Medtronic Activa Tremor Control System. Also approval for labeling modifications.
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