Deep Brain Stimulation (DBS) System
FDA premarket approval P140009/S079 · decided 2022-10-17
Approval details
- PMA number
- P140009
- Supplement
- S079
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Deep Brain Stimulation (DBS) System
- Generic name
- Stimulator, electrical, implanted, for parkinsonian tremor
- Applicant
- ABBOTT MEDICAL
- Date received
- 2022-09-21
- Decision date
- 2022-10-17
- Days to decision
- 26 days
- Decision code
- OK30
- Product code
- MHY
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Plano, TX
- Statement
- Qualify an additional manufacturing site in Bethel, Connecticut to manufacture nitinol tubes, which will be used in the manufacture of the DBS Extensions.
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