SenSight Directional Lead Kit
FDA premarket approval P960009/S407 · decided 2021-09-09
Approval details
- PMA number
- P960009
- Supplement
- S407
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- SenSight Directional Lead Kit
- Generic name
- Stimulator, electrical, implanted, for parkinsonian tremor
- Applicant
- Medtronic, Inc.
- Date received
- 2021-08-11
- Decision date
- 2021-09-09
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- MHY
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- Add a duplicate inspection to the SenSight Lead Stringing Work Instructions for SenSight Lead Coil subassemblies used in models B33005 and B33015. The updated manufacturing process impacts subcomponents for the SenSight Directional Lead occurring at the Medtronic Danvers facility located in Danvers, MA.
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510(k) clearances by this applicant
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|---|---|---|
| VitalFlow Set with Balance™ Biosurface (K261335) | Medtronic, Inc. | 2026-07-31 |
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| Bio-Medicus Life Support Catheter and Introducer (K251831) | Medtronic, Inc. | 2026-01-15 |
| Concerto Versa™ Detachable Coil (K253511) | Medtronic, Inc. | 2026-01-14 |
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