ITRELL 3, SYNERGY AND SYNGERY VERSITREL SPINAL CORD STIMULATION SYSTEMS
FDA premarket approval P840001/S072 · decided 2004-04-15
Approval details
- PMA number
- P840001
- Supplement
- S072
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- ITRELL 3, SYNERGY AND SYNGERY VERSITREL SPINAL CORD STIMULATION SYSTEMS
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Applicant
- Medtronic Neuromodulation
- Date received
- 2004-03-04
- Decision date
- 2004-04-15
- Days to decision
- 42 days
- Decision code
- APPR
- Product code
- LGW
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- APPROVAL TO USE EALSTHANE RESINS AS ALTERNATE MATERIALS TO PELLETHANE RESINS IN LEADS, EXTENSIONS AND ACCESSORIES. THE FOLLOWING LEADS, EXTENSIONS AND ACCESSORIES WILL BE AFFECTED: MODEL 3487A - PISCES QUAD, MODEL 3887 - PISCES QUAD COMPACT, MODEL 3888 - PISCES QUAD PLUS, MODEL 3890 - PISCES Z QUAD, MODEL 3891 - PISCES Z QUAD COMPACT, MODEL 3892 - PISCES Z QUAD PLUS, MODEL 3898 - PISCES OCTAD, MODEL 3998 - SPECIFY, MODEL 3982A - SYMMIX, MODEL 3861 - TEMPORARY SCREENING LEAD, MODEL 3862 - VERIFY,
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| Record | Firm | Date |
|---|---|---|
| SureTune4 Software (DEN210003) | Medtronic Neuromodulation | 2021-08-23 |