Infinity family of DBS IPGs
FDA premarket approval P140009/S064 · decided 2021-03-05
Approval details
- PMA number
- P140009
- Supplement
- S064
- Supplement type
- Normal 180 Day Track
- 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
- 2020-09-09
- Decision date
- 2021-03-05
- Days to decision
- 177 days
- Decision code
- APPR
- Product code
- MHY
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Plano, TX
- Statement
- Approval for an update to the Clinician Programmer Application and Patient Controller Application to version 202.0 to include a Remote Care feature that facilitates remote communication between the Clinician Programmer Application and Patient Programmer Application.
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510(k) clearances by this applicant
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|---|---|---|
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| Assert-IQ (DM5100) (K253516) | ABBOTT MEDICAL | 2025-12-18 |