MEDTRONIC ITREL SPINAL CORD STIMULATION SYSTEM
FDA premarket approval P840001/S040 · decided 1997-04-25
Approval details
- PMA number
- P840001
- Supplement
- S040
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- MEDTRONIC ITREL SPINAL CORD STIMULATION SYSTEM
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Applicant
- Medtronic Neuromodulation
- Date received
- 1996-02-06
- Decision date
- 1997-04-25
- Days to decision
- 444 days
- Decision code
- APPR
- Product code
- LGW
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- APPROVAL FOR DESIGN CHANGES FOR THE ITREL(R) SERIES OF NEUROLOGICAL PULSE GENERATORS, INCLUDING THE INTREL(R), ITREL(R) II, AND ITREL(R) 3.
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| Record | Firm | Date |
|---|---|---|
| SureTune4 Software (DEN210003) | Medtronic Neuromodulation | 2021-08-23 |