Activa Deep Brain Stimulation Therapy System
FDA premarket approval P960009/S356 · decided 2019-08-22
Approval details
- PMA number
- P960009
- Supplement
- S356
- 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
- 2019-07-29
- Decision date
- 2019-08-22
- Days to decision
- 24 days
- Decision code
- OK30
- Product code
- MHY
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- Implementation of process controls for Soft Straight-Line Finish (SLF) cosmetic rework at Medtronics final device manufacturing facilities-Medtronic Puerto Rico Operations Company (MPROC), located in Juncos, Puerto Rico.
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