MEDTRONIC ACTIVA TREMOR CONTROL SYSTEM
FDA premarket approval P960009/S248 · decided 2016-03-31
Approval details
- PMA number
- P960009
- Supplement
- S248
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- MEDTRONIC ACTIVA TREMOR CONTROL SYSTEM
- Generic name
- Stimulator, electrical, implanted, for parkinsonian tremor
- Applicant
- Medtronic, Inc.
- Date received
- 2016-03-04
- Decision date
- 2016-03-31
- Days to decision
- 27 days
- Decision code
- OK30
- Product code
- MHY
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- Assembly of hybrid assemblies manufactured at Medtronic Tempe Campus using the Assembleon Pick and Place machine.
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