SURESCAN MRI IMPLANTABLE NEUROSTIMULATION SYSTEM
FDA premarket approval P840001/S219 · decided 2013-03-20
Approval details
- PMA number
- P840001
- Supplement
- S219
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- SURESCAN MRI IMPLANTABLE NEUROSTIMULATION SYSTEM
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Applicant
- Medtronic Neuromodulation
- Date received
- 2012-07-03
- Decision date
- 2013-03-20
- Days to decision
- 260 days
- Decision code
- APPR
- Product code
- LGW
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- APPROVAL FOR OF THE MEDTRONIC SURESCANTM MRI IMPLANTABLE NEUROSTIMULATION SYSTEM, WHICH CONSISTS OF THE PRIMEADVANCED SURESCAN¿ MRI IPG MODEL 97702; RESTOREULTRA SURESCAN¿ MRI IPG MODEL 97712; RESTOREADVANCED SURESCAN¿ MRI IPG MODEL 97713;RESTORESENSOR SURESCAN¿ MRI IPG MODEL 97714; VECTRIS SURESCANTM MRI 1X8 SUBCOMPACT LEADS MODELS 977A160, 977A175, AND 977A190; VECTRIS SURESCANTM MRI 1X8 COMPACT LEADS MODELS 977A260, 977A275, AND 977A290; VECTRIS 1X8 SUBCOMPACT TRIALING LEAD MODEL977D160; VECT
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| SureTune4 Software (DEN210003) | Medtronic Neuromodulation | 2021-08-23 |