ACTIVA TREMOR CONTROL SYSTEM
FDA premarket approval P960009/S022 · decided 2001-12-11
Approval details
- PMA number
- P960009
- Supplement
- S022
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- ACTIVA TREMOR CONTROL SYSTEM
- Generic name
- Stimulator, electrical, implanted, for parkinsonian tremor
- Applicant
- Medtronic, Inc.
- Date received
- 2001-11-13
- Decision date
- 2001-12-11
- Days to decision
- 28 days
- Decision code
- APPR
- Product code
- MHY
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- APPROVAL FOR A CHANGE TO THE MANUFACTURING PROCESS TO INCLUDE AN ADDITIONAL METHOD FOR MONITORING ETHYLENE GAS CONCENTRATIONS DURING THE STERILIZATION PROCESS.
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