ITREL SPINAL CORD STIMULATION SYSTEM
FDA premarket approval P840001/S041 · decided 1998-01-20
Approval details
- PMA number
- P840001
- Supplement
- S041
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- ITREL SPINAL CORD STIMULATION SYSTEM
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Applicant
- Medtronic Neuromodulation
- Date received
- 1997-07-24
- Decision date
- 1998-01-20
- Days to decision
- 180 days
- Decision code
- APPR
- Product code
- LGW
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- Approval for the use of an alternative packaging material, uncoated PETG (polyethylene terephthalate, glycol modifed) for the manufacture of the inner and outer packaging trays. The device, as modified, will be marketed under the trade name Itrel and is indicated for Spinal Cord Stimulation.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| SureTune4 Software (DEN210003) | Medtronic Neuromodulation | 2021-08-23 |