Restore, Itrel, Synergy, Intellis , Vanta and Sequentia LT Spinal Cord Stimulation Systems and Pisces, Specify, and Vect
FDA premarket approval P840001/S493 · decided 2021-06-30
Approval details
- PMA number
- P840001
- Supplement
- S493
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Restore, Itrel, Synergy, Intellis , Vanta and Sequentia LT Spinal Cord Stimulation Systems and Pisces, Specify, and Vect
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Applicant
- Medtronic Neuromodulation
- Date received
- 2021-06-23
- Decision date
- 2021-06-30
- Days to decision
- 7 days
- Decision code
- OK30
- Product code
- LGW
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- Newly defined and characterized solder paste inspection (SPI) process at Medtronic Tempe Campus (MTC), Medtronics internal supplier of hybrids used in the manufacturing of Medtronic Neuromodulation (Neuro) products.
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 |