Activa Deep Brian Stimulation Therapy System
FDA premarket approval P960009/S327 · decided 2018-11-08
Approval details
- PMA number
- P960009
- Supplement
- S327
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Activa Deep Brian Stimulation Therapy System
- Generic name
- Stimulator, electrical, implanted, for parkinsonian tremor
- Applicant
- Medtronic, Inc.
- Date received
- 2018-10-10
- Decision date
- 2018-11-08
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- MHY
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- Implementation of the impacted Medtronic Neuromodulation Lithium-Ion batteries on the Universal Burn-In Test System (UBITS) Load Station 4 for production use at Medtronics first tier supplier Medtronic Energy and Component Center (MECC).
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