MEDTRONIC ACTIVA DEEP BRAIN STIMULATION SYSTEMS
FDA premarket approval P960009/S035 · decided 2005-12-06
Approval details
- PMA number
- P960009
- Supplement
- S035
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- MEDTRONIC ACTIVA DEEP BRAIN STIMULATION SYSTEMS
- Generic name
- Stimulator, electrical, implanted, for parkinsonian tremor
- Applicant
- Medtronic, Inc.
- Date received
- 2005-11-04
- Decision date
- 2005-12-06
- Days to decision
- 32 days
- Decision code
- APPR
- Product code
- MHY
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- APPROVAL FOR RECOMMENDING MAXIMUM DISPLAYED HEAD SAR TO BE 0.1 W/KG WITH RESPECT TO THE MRI (MAGNETIC RESONANCE IMAGING) INSTRUCTIONS.
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