SOLETRA, KINETRA, ACTIVA SC
FDA premarket approval P960009/S158 · decided 2012-10-24
Approval details
- PMA number
- P960009
- Supplement
- S158
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- SOLETRA, KINETRA, ACTIVA SC
- Generic name
- Stimulator, electrical, implanted, for parkinsonian tremor
- Applicant
- Medtronic, Inc.
- Date received
- 2012-09-25
- Decision date
- 2012-10-24
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- MHY
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- MANUFACTURE OF ONE INNER SEAL SILICONE COMPONENT AT THE ALTERNATE SUPPLIER, FLEXAN LOCATED IN SUZHOU INDUSTRIAL PARK, CHINA.
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510(k) clearances by this applicant
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| Concerto Versa™ Detachable Coil (K253511) | Medtronic, Inc. | 2026-01-14 |
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