SCS ACCESSORIES,SCS 1X8 EXTENSION,SCS QUADRIPOLAR EXTENSION,SCS LEADS SPECIFY FAMILY,SCS LEADS 1X8 FAMILY,SCS LEADS
FDA premarket approval P840001/S231 · decided 2013-01-08
Approval details
- PMA number
- P840001
- Supplement
- S231
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- SCS ACCESSORIES,SCS 1X8 EXTENSION,SCS QUADRIPOLAR EXTENSION,SCS LEADS SPECIFY FAMILY,SCS LEADS 1X8 FAMILY,SCS LEADS
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Applicant
- Medtronic Neuromodulation
- Date received
- 2012-12-11
- Decision date
- 2013-01-08
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- LGW
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- USE AN UPDATED VERSION OF THE SOFTWARE ALREADY IN USE AT VARIOUS FACILITIES TO ENSURE COMPLIANCE TO TRAINING REQUIREMENTS, PROPER DOCUMENTATION ASSOCIATED WITH DISPOSITION OF PRODUCT, AND PROPER FUNCTION OF THE SOFTWARE BY CORRECTING MINOR ISSUES PRESENT IN THE CURRENT SOFTWARE VERSION.
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 |