Restore, ltrel, and Synergy Spinal Cord Stimulation Systems and Pisces, Resume, Specify, and Vectris Spinal Cord Stimula
FDA premarket approval P840001/S333 · decided 2016-07-27
Approval details
- PMA number
- P840001
- Supplement
- S333
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Restore, ltrel, and Synergy Spinal Cord Stimulation Systems and Pisces, Resume, Specify, and Vectris Spinal Cord Stimula
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Applicant
- Medtronic Neuromodulation
- Date received
- 2016-06-27
- Decision date
- 2016-07-27
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- LGW
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- Update to the welding process parameters, welding electrode tip geometry, and accompanying documentation used in the manufacture of your Medium Rate battery assemblies for your Restore, Itrel, and Synergy Spinal Cord Stimulation (SCS) Systems; Activa Deep Brain Stimulation (DBS) Therapy System; Activa Dystonia Therapy System; Reclaim DBS Therapy for OCD System; InterStim Therapy System; Enterra Therapy System; and SyncroMed Infusion System.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| SureTune4 Software (DEN210003) | Medtronic Neuromodulation | 2021-08-23 |