ITREL(R) 3 SYSTEM
FDA premarket approval P840001/S050 · decided 2001-07-26
Approval details
- PMA number
- P840001
- Supplement
- S050
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- ITREL(R) 3 SYSTEM
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Applicant
- Medtronic Neuromodulation
- Date received
- 2001-01-29
- Decision date
- 2001-07-26
- Days to decision
- 178 days
- Decision code
- APPR
- Product code
- LGW
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- APPROVAL FOR THE ITREL(R) EZ(TM) MODEL 7434A PATIENT PROGRAMMER, TO BE USED WITH THE MODEL 7425 ITREL(R) 3 IMPLANTABLE PULSE GENERATOR, AND LABELING MODIFICATIONS RESULTING FROM THE INTRODUCTION OF THE NEW PATIENT PROGRAMMER.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| SureTune4 Software (DEN210003) | Medtronic Neuromodulation | 2021-08-23 |