MEDTRONIC ACTIVA RC AND PC NEUROSTIMULATORS
FDA premarket approval P960009/S083 · decided 2010-06-28
Approval details
- PMA number
- P960009
- Supplement
- S083
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- MEDTRONIC ACTIVA RC AND PC NEUROSTIMULATORS
- Generic name
- Stimulator, electrical, implanted, for parkinsonian tremor
- Applicant
- Medtronic, Inc.
- Date received
- 2010-05-03
- Decision date
- 2010-06-28
- Days to decision
- 56 days
- Decision code
- APPR
- Product code
- MHY
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- APPROVAL FOR MINOR FIRMWARE DESIGN CHANGES TO AUTOMATE THE HANDLING OF MOST POR (POWER ON RESET) EVENTS IN THE ¿ACTIVA RC AND ACTIVA PC NEUROSTIMULATOR.
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