Itrel, Synergy and Intellis Spinal Cord Stimulation Systems and Pisces, Specify, and Vectris Spinal Cord Stimulation Lea
FDA premarket approval P840001/S413 · decided 2018-11-08
Approval details
- PMA number
- P840001
- Supplement
- S413
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Itrel, Synergy and Intellis Spinal Cord Stimulation Systems and Pisces, Specify, and Vectris Spinal Cord Stimulation Lea
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Applicant
- Medtronic Neuromodulation
- Date received
- 2018-10-30
- Decision date
- 2018-11-08
- Days to decision
- 9 days
- Decision code
- OK30
- Product code
- LGW
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- Consolidate the laser weld pull strength monitoring tests for four model families into one group (affected models: 977A160, 977A175, 977A190, 977A260, 977A275, 977A290, 977D160, 977D260, 3776, 3777, 3778, 37081, 37082, 37083, 37085, 37086).
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| SureTune4 Software (DEN210003) | Medtronic Neuromodulation | 2021-08-23 |