Restore, Itrel, Synergy and Intellis Spinal Cord Stimulation Systems and Pisces, Specify, and Vectris Spinal Cord Stimul
FDA premarket approval P840001/S484 · decided 2021-08-30
Approval details
- PMA number
- P840001
- Supplement
- S484
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Restore, Itrel, Synergy and Intellis Spinal Cord Stimulation Systems and Pisces, Specify, and Vectris Spinal Cord Stimul
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Applicant
- Medtronic Neuromodulation
- Date received
- 2021-01-25
- Decision date
- 2021-08-30
- Days to decision
- 217 days
- Decision code
- APPR
- Product code
- LGW
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- Approval for a cleaning process change at DSM Biomedical in Berkeley California, a supplier to Medtronic Neuromodulation, that involves the addition of an option to replace solvent cleaning the equipment between material lots with a process that uses the next lot of material to purge the system (the first 30 seconds of material coming out of this portion of the manufacturing line is discarded). The change involves the continuous reactor system to be purged between production batches of same hard
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| SureTune4 Software (DEN210003) | Medtronic Neuromodulation | 2021-08-23 |