ITREL EZ PATIENT PROGRAMMER,SYNERGY EZ PATIENT PROGRAMMER,ACCESS THERAPY PATIENT CONTROLLER
FDA premarket approval P840001/S242 · decided 2016-04-29
Approval details
- PMA number
- P840001
- Supplement
- S242
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- ITREL EZ PATIENT PROGRAMMER,SYNERGY EZ PATIENT PROGRAMMER,ACCESS THERAPY PATIENT CONTROLLER
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Applicant
- Medtronic Neuromodulation
- Date received
- 2013-06-06
- Decision date
- 2016-04-29
- Days to decision
- 1058 days
- Decision code
- APPR
- Product code
- LGW
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- Approval for the replacement of the battery compartment labels of the hand-held patient programmers with labels whole pressure sensitive is resistant to the effects of high humidity.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| SureTune4 Software (DEN210003) | Medtronic Neuromodulation | 2021-08-23 |