Activa Deep Brain Stimulation Therapy System
FDA premarket approval P960009/S255 · decided 2016-07-27
Approval details
- PMA number
- P960009
- Supplement
- S255
- Supplement type
- 30-Day Notice
- Supplement reason
- Process 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
- 2016-06-27
- Decision date
- 2016-07-27
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- MHY
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- Update to the welding process parameters, welding electrode tip geometry, and accompanying documentation used in the manufacture of your Medium Rate battery assemblies for your Restore, Itrel, and Synergy Spinal Cord Stimulation (SCS) Systems; Activa Deep Brain Stimulation (DBS) Therapy System; Activa Dystonia Therapy System; Reclaim DBS Therapy for OCD System; InterStim Therapy System; Enterra Therapy System; and SyncroMed Infusion System.
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