BRIO NEUROSTIMULATION SYSTEM
FDA premarket approval P140009/S013 · decided 2016-04-20
Approval details
- PMA number
- P140009
- Supplement
- S013
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- BRIO NEUROSTIMULATION SYSTEM
- Generic name
- Stimulator, electrical, implanted, for parkinsonian tremor
- Applicant
- ABBOTT MEDICAL
- Date received
- 2016-03-21
- Decision date
- 2016-04-20
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- MHY
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Plano, TX
- Statement
- Change to the electrode manufacturing process and a replacement of 100% inspection with an AQL sampling plan for the Spinal Cord Stimulation (SCS) and Deep Brain Stimulation (DBS) leads, extensions, and adapters.
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