Restore, Itrel, Synergy and Intellis Sprinal Cord Stimulation Systems and Pisces, Specify,adn Vectris Sprinal Cord Stimu
FDA premarket approval P840001/S369 · decided 2017-08-24
Approval details
- PMA number
- P840001
- Supplement
- S369
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Restore, Itrel, Synergy and Intellis Sprinal Cord Stimulation Systems and Pisces, Specify,adn Vectris Sprinal Cord Stimu
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Applicant
- Medtronic Neuromodulation
- Date received
- 2017-07-27
- Decision date
- 2017-08-24
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- LGW
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- Transfer of receiving and incoming inspection activities for device components (i.e., Screw-Conn Set, Crimp Block 7495, and Block- Connector, Set Screw) used in the manufacture of Medtronic Neuromodulation therapy delivery products, from the Medtronic Rice Creek facility to the Medtronic Puerto Rico Operations Company (MPROC)-Villalba, MPROC-Juncos, and the FedEx/3PL (Third Party Logistics) facility in Guaynabo, Puerto Rico.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| SureTune4 Software (DEN210003) | Medtronic Neuromodulation | 2021-08-23 |