Infinity family of DBS IPGs
FDA premarket approval P140009/S030 · decided 2017-12-09
Approval details
- PMA number
- P140009
- Supplement
- S030
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Infinity family of DBS IPGs
- Generic name
- Stimulator, electrical, implanted, for parkinsonian tremor
- Applicant
- ABBOTT MEDICAL
- Date received
- 2017-09-11
- Decision date
- 2017-12-09
- Days to decision
- 89 days
- Decision code
- APPR
- Product code
- MHY
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Plano, TX
- Statement
- Approval for updated versions of the Clinician Programmer and Patient Controller software (v 3.6) that include new methods for calculating battery status and recovering system functions after exposure to power disturbances.
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