PROTEGE NEUROSTIMULATION SYSTEM
FDA premarket approval P010032/S079 · decided 2014-07-14
Approval details
- PMA number
- P010032
- Supplement
- S079
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- PROTEGE NEUROSTIMULATION SYSTEM
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Applicant
- ABBOTT MEDICAL
- Date received
- 2014-04-15
- Decision date
- 2014-07-14
- Days to decision
- 90 days
- Decision code
- APPR
- Product code
- LGW
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Plano, TX
- Statement
- APPROVAL FOR RAPID PROGRAMMER VERSION 3.6 TO SUPPORT THEPROGRAMMING OF THE PROTÉGÉ NEUROSTIMULATION DEVICES (MODEL 3789 PROTÉGÉ IMPLANTABLE PULSE GENERATOR AND MODEL 3852 PATIENT PROGRAMMER) AS WELL AS TO MAKE MINOR SUSTAINING ENHANCEMENTS.
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