MRDTRONIC ACTIVA TREMOR CONTROL SYSTEM
FDA premarket approval P960009/S004 · decided 1999-03-25
Approval details
- PMA number
- P960009
- Supplement
- S004
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- MRDTRONIC ACTIVA TREMOR CONTROL SYSTEM
- Generic name
- Stimulator, electrical, implanted, for parkinsonian tremor
- Applicant
- Medtronic, Inc.
- Date received
- 1998-12-29
- Decision date
- 1999-03-25
- Days to decision
- 86 days
- Decision code
- APPR
- Product code
- MHY
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- Approval for corrections to an educational brochure which contains instructions for routing and implantation of the lead to extension connection and the addition of a new warning label.
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