Deep Brain Stimulation (DBS) Implantable Pulse Generator (IPG)
FDA premarket approval P140009/S094 · decided 2024-04-05
Approval details
- PMA number
- P140009
- Supplement
- S094
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Deep Brain Stimulation (DBS) Implantable Pulse Generator (IPG)
- Generic name
- Stimulator, electrical, implanted, for parkinsonian tremor
- Applicant
- ABBOTT MEDICAL
- Date received
- 2024-03-07
- Decision date
- 2024-04-05
- Days to decision
- 29 days
- Decision code
- APPR
- Product code
- MHY
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Plano, TX
- Statement
- revert manufacturing of IPG boards for SCS, DRG and DBS to original C68 component
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