Activa Deep Brain Stimulation Therapy System
FDA premarket approval P960009/S294 · decided 2018-04-13
Approval details
- PMA number
- P960009
- Supplement
- S294
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Activa Deep Brain Stimulation Therapy System
- Generic name
- Stimulator, electrical, implanted, for parkinsonian tremor
- Applicant
- Medtronic, Inc.
- Date received
- 2017-09-05
- Decision date
- 2018-04-13
- Days to decision
- 220 days
- Decision code
- APPR
- Product code
- MHY
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- Approval for a manufacturing site located at Road 31, Km. 24, Hm 4, Ceiba Norte Industrial Park, Juncos, Puerto Rico 00777, for kitting activities including Sterile Packaging, Sterilization, Final Pack & Label, and Final QA Inspection.
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