Master Restore, Itrel, Synergy and Intellis Spinal Cord Stimulation Systems and Pisces Specify and Vectris Spinal Cord S
FDA premarket approval P840001/S377 · decided 2018-04-13
Approval details
- PMA number
- P840001
- Supplement
- S377
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Master Restore, Itrel, Synergy and Intellis Spinal Cord Stimulation Systems and Pisces Specify and Vectris Spinal Cord S
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Applicant
- Medtronic Neuromodulation
- Date received
- 2017-09-05
- Decision date
- 2018-04-13
- Days to decision
- 220 days
- Decision code
- APPR
- Product code
- LGW
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- Approval for a manufacturing site located at Road 31, Km. 24, Hm 4, Ceiba Norte Industrial Park, Juncos, Puerto Rico 00777, for kitting activities including Sterile Packaging, Sterilization, Final Pack & Label, and Final QA Inspection.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.
510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| SureTune4 Software (DEN210003) | Medtronic Neuromodulation | 2021-08-23 |