MEDTRONIC NEUROMODULATION DEEP BRAIN STIMULATION SYSTEMS
FDA premarket approval P960009/S073 · decided 2010-06-01
Approval details
- PMA number
- P960009
- Supplement
- S073
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- MEDTRONIC NEUROMODULATION DEEP BRAIN STIMULATION SYSTEMS
- Generic name
- Stimulator, electrical, implanted, for parkinsonian tremor
- Applicant
- Medtronic, Inc.
- Date received
- 2009-12-03
- Decision date
- 2010-06-01
- Days to decision
- 180 days
- Decision code
- APPR
- Product code
- MHY
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- APPROVAL FOR REVISED LABELING FOR THE DEVICE. THE CHANGES CONSIST OF ORGANIZATION, EDITORIAL, AND CONTENT REVISIONS, WHICH INCLUDE THE ADDITION OF NEW WARNINGS AND CONTRAINDICATIONS.
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510(k) clearances by this applicant
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