ACTIVA THERAPY FOR DEEP BRAIN STIMULATION
FDA premarket approval P960009/S042 · decided 2007-10-17
Approval details
- PMA number
- P960009
- Supplement
- S042
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- ACTIVA THERAPY FOR DEEP BRAIN STIMULATION
- Generic name
- Stimulator, electrical, implanted, for parkinsonian tremor
- Applicant
- Medtronic, Inc.
- Date received
- 2007-09-17
- Decision date
- 2007-10-17
- Days to decision
- 30 days
- Decision code
- APPR
- Product code
- MHY
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- APPROVAL FOR TE ADDITION OF A PRECAUTION TO PATIENT MANUALS OF THE MODEL 7436 AND MODEL 7438 THERAPY CONTROLLERS.
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