POCKET ADAPTOR KIT, ITREL 3, SYNERGY & SYNERGY VERSITREL
FDA premarket approval P840001/S205 · decided 2012-04-12
Approval details
- PMA number
- P840001
- Supplement
- S205
- Supplement type
- 30-Day Notice
- Trade name
- POCKET ADAPTOR KIT, ITREL 3, SYNERGY & SYNERGY VERSITREL
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Applicant
- Medtronic Neuromodulation
- Date received
- 2012-03-16
- Decision date
- 2012-04-12
- Days to decision
- 27 days
- Decision code
- OK30
- Product code
- LGW
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- ADD TWO ALTERNATE SUPPLIERS FOR THE OUTER SEAL COMPONENT.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| SureTune4 Software (DEN210003) | Medtronic Neuromodulation | 2021-08-23 |