INFINITY NEUROSTIMULATION SYSTEM
FDA premarket approval P010032/S097 · decided 2016-09-19
Approval details
- PMA number
- P010032
- Supplement
- S097
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- INFINITY NEUROSTIMULATION SYSTEM
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Applicant
- ABBOTT MEDICAL
- Date received
- 2015-07-02
- Decision date
- 2016-09-19
- Days to decision
- 445 days
- Decision code
- APPR
- Product code
- LGW
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Plano, TX
- Statement
- Approval for the Clinician Programmer App (Version 3.1) Model 3874, Programmer App (Version 3.1) Model 3875, and the Infinity Neurostimulation System.
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