Restore, Itrel, Synergy, and Intellis Spinal Cord Stimulation Systems and Pisces, Specify, and Vectris Spinal Cord Stimu
FDA premarket approval P840001/S448 · decided 2019-12-11
Approval details
- PMA number
- P840001
- Supplement
- S448
- Supplement type
- 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 Stimu
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Applicant
- Medtronic Neuromodulation
- Date received
- 2019-11-15
- Decision date
- 2019-12-11
- Days to decision
- 26 days
- Decision code
- OK30
- Product code
- LGW
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- Update Medtronics manufacturing software, Manufacturing Execution System to Factory Works (Release 9.7), which is comprised of (1) FW Business Rule Client 9.7, (2) FW Configuration Client 9.2.2, and (3) Integrated Manufacturing Process Management (iMPM) Web Services (WS) 3.6.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| SureTune4 Software (DEN210003) | Medtronic Neuromodulation | 2021-08-23 |