ACTIVA DEEP BRAIN STIMULATION THERAPY SYSTEM
FDA premarket approval P960009/S220 · decided 2015-05-11
Approval details
- PMA number
- P960009
- Supplement
- S220
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- ACTIVA DEEP BRAIN STIMULATION THERAPY SYSTEM
- Generic name
- Stimulator, electrical, implanted, for parkinsonian tremor
- Applicant
- Medtronic, Inc.
- Date received
- 2015-02-27
- Decision date
- 2015-05-11
- Days to decision
- 73 days
- Decision code
- APPR
- Product code
- MHY
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- APPROVAL FOR MATERIAL CHANGES TO TWO NON-IMPLANTABLE SCREENING CABLES (THE ALLIGATOR CLIP SCREENING CABLE ACCESSORY KIT AND THE TWIST LOCK SCREENING CABLE ACCESSORY KIT) TO COMPLY WITH THE EUROPEAN UNION RESTRICTION OF HAZARDOUS SUBSTANCES II DIRECTIVE 2011/65/EU.
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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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