MEDTRONIC MODEL 7424 ITREL(R) II, MODEL 7425 ITREL(R) III, AND MODEL 7427 SYNEEDRGY SPINAL CORD STIMULATION SYSTEMS
FDA premarket approval P840001/S055 · decided 2001-08-14
Approval details
- PMA number
- P840001
- Supplement
- S055
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- MEDTRONIC MODEL 7424 ITREL(R) II, MODEL 7425 ITREL(R) III, AND MODEL 7427 SYNEEDRGY SPINAL CORD STIMULATION SYSTEMS
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Applicant
- Medtronic Neuromodulation
- Date received
- 2001-07-10
- Decision date
- 2001-08-14
- Days to decision
- 35 days
- Decision code
- APPR
- Product code
- LGW
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- APPROVAL FOR AN ADDITIONAL QUALITY CONTROL STEP TO VERIFY THAT THE NEUROSTIMULATORS ARE MANUFACTURED TO THERI SPECIFICATION, I.E. THAT THE NEUROSTIMULATOR HAS THE SPECIFIED INSULATION BETWEEN THE BATTERY AND THE INTERNAL SURFACE OF THE TITANIUM (CASE) SHIELD.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| SureTune4 Software (DEN210003) | Medtronic Neuromodulation | 2021-08-23 |