Deep Brain Stimulation (DBS) System
FDA premarket approval P140009/S073 · decided 2021-12-30
Approval details
- PMA number
- P140009
- Supplement
- S073
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location 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
- 2021-09-27
- Decision date
- 2021-12-30
- Days to decision
- 94 days
- Decision code
- APPR
- Product code
- MHY
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Plano, TX
- Statement
- Approval to add Midwest Sterilization Corporation located at 1204 Lenco Ave. Jackson, Mo 63755 as an alternate ethylene oxide (EO) sterility facility.
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