Infinity Deep Brain Stimulation (DBS) Implantable Pulse Generator (IPG)
FDA premarket approval P140009/S076 · decided 2022-03-24
Approval details
- PMA number
- P140009
- Supplement
- S076
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Infinity Deep Brain Stimulation (DBS) Implantable Pulse Generator (IPG)
- Generic name
- Stimulator, electrical, implanted, for parkinsonian tremor
- Applicant
- ABBOTT MEDICAL
- Date received
- 2022-02-22
- Decision date
- 2022-03-24
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- MHY
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Plano, TX
- Statement
- Update to the Post-Header Test System Non-Product Software used during assembly of Orion family (Proclaim SCS, Infinity DBS, Proclaim DRG) Implantable Pulse Generators (IPGs).
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