MEDTRONIC ACTIVA PARKINSON CONTROL SYSTEM
FDA premarket approval P960009/S024 · decided 2002-07-29
Approval details
- PMA number
- P960009
- Supplement
- S024
- Supplement type
- Real-Time Process
- Supplement reason
- Other
- Trade name
- MEDTRONIC ACTIVA PARKINSON CONTROL SYSTEM
- Generic name
- Stimulator, electrical, implanted, for parkinsonian tremor
- Applicant
- Medtronic, Inc.
- Date received
- 2002-02-25
- Decision date
- 2002-07-29
- Days to decision
- 154 days
- Decision code
- APPR
- Product code
- MHY
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- APPROVAL FOR MINOR CHANGES TO THE LABELING OF THE EXISTING MEDTRONIC ACCESS REVIEW MODEL 7438 THERAPY CONTROLLER TO BE USED WITH MEDTRONIC ACTIVA PARKINSON'S CONTROL SYSTEM.
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