Restore, Itrel, Synergy and Intellis Spinal Cord Stimulation Systems and Pisces, Specify and Vectris Spinal Cord Stimula
FDA premarket approval P840001/S376 · decided 2018-03-11
Approval details
- PMA number
- P840001
- Supplement
- S376
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Restore, Itrel, Synergy and Intellis Spinal Cord Stimulation Systems and Pisces, Specify and Vectris Spinal Cord Stimula
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Applicant
- Medtronic Neuromodulation
- Date received
- 2017-09-01
- Decision date
- 2018-03-11
- Days to decision
- 191 days
- Decision code
- APPR
- Product code
- LGW
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- Approval for a manufacturing site located at Medronic Puerto Rico Operations Company, Villalba, Rd. 149, Km 56.3 , Cal box 6001, Villaba, Puerto Rico for manufacture of the 1x4 Pocket Adaptors (models 74001 and 64001) and 2x4 Pocket Adaptors (models 74002 and 64002).
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| SureTune4 Software (DEN210003) | Medtronic Neuromodulation | 2021-08-23 |