MEDTRONIC ACTIVA TREMOR CONTROL SYSTEM
FDA premarket approval P960009/S003 · decided 1999-09-30
Approval details
- PMA number
- P960009
- Supplement
- S003
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- MEDTRONIC ACTIVA TREMOR CONTROL SYSTEM
- Generic name
- Stimulator, electrical, implanted, for parkinsonian tremor
- Applicant
- Medtronic, Inc.
- Date received
- 1998-10-08
- Decision date
- 1999-09-30
- Days to decision
- 357 days
- Decision code
- APPR
- Product code
- MHY
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- Approval for the Model 3389 DBS(TM) Lead (as an alternative tot he existing Model 3387 DBS(TM) Lead) for use in conjunction with the existing Medtronic Activa Tremor Control System.
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