ACTIVA PARKINSON'S CONTROL THERAPY
FDA premarket approval P960009/S030 · decided 2005-01-14
Approval details
- PMA number
- P960009
- Supplement
- S030
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Trade name
- ACTIVA PARKINSON'S CONTROL THERAPY
- Generic name
- Stimulator, electrical, implanted, for parkinsonian tremor
- Applicant
- Medtronic, Inc.
- Date received
- 2004-07-20
- Decision date
- 2005-01-14
- Days to decision
- 178 days
- Decision code
- APPR
- Product code
- MHY
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- APPROVAL FOR A REVISED POST-APPROVAL STUDY FOR THE DEVICE.
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510(k) clearances by this applicant
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|---|---|---|
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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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