RESTORE, ITREL, AND SYNERGY SPINAL CORD STIMULATION SYSTEM AND PISCES, RESUME, SPECIFY, AND VECTRIS SPINAL CORD STIMULAT
FDA premarket approval P840001/S309 · decided 2015-08-20
Approval details
- PMA number
- P840001
- Supplement
- S309
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- RESTORE, ITREL, AND SYNERGY SPINAL CORD STIMULATION SYSTEM AND PISCES, RESUME, SPECIFY, AND VECTRIS SPINAL CORD STIMULAT
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Applicant
- Medtronic Neuromodulation
- Date received
- 2015-07-23
- Decision date
- 2015-08-20
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- LGW
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- CHANGES TO THE FINAL FUNCTIONAL TESTING (FFT) SOFTWARE OF THE IMPLANTABLE NEUROSTIMULATORS AT MEDTRONIC PUERTO RICO OPERATIONS IN JUNCOS, PUERTO RICO.
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 |