Restore, Itrel, and Synergy Spinal Cord Stimulation Systems and Pisces, Specify and Vectris Spinal Cord Stimulation Lead
FDA premarket approval P840001/S375 · decided 2017-09-22
Approval details
- PMA number
- P840001
- Supplement
- S375
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Restore, Itrel, and Synergy Spinal Cord Stimulation Systems and Pisces, Specify and Vectris Spinal Cord Stimulation Lead
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Applicant
- Medtronic Neuromodulation
- Date received
- 2017-08-24
- Decision date
- 2017-09-22
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- LGW
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- Make a sub-tier supplier change to source a hypotube that will be coated with PTFE without the presence of PFOA as a manufacturing aid; 2) mask the flared portion of the hypotube during manufacturing to eliminate PTFE coating during forming operations; and 3) update the product specification to the correct referenced standard for EN 45502. i.e. The Change in particulate matter standard EN45502-1.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| SureTune4 Software (DEN210003) | Medtronic Neuromodulation | 2021-08-23 |