ACTIVA DEEP BRAIN STIMULATION SYSTEM
FDA premarket approval P960009/S197 · decided 2014-12-05
Approval details
- PMA number
- P960009
- Supplement
- S197
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- ACTIVA DEEP BRAIN STIMULATION SYSTEM
- Generic name
- Stimulator, electrical, implanted, for parkinsonian tremor
- Applicant
- Medtronic, Inc.
- Date received
- 2014-06-19
- Decision date
- 2014-12-05
- Days to decision
- 169 days
- Decision code
- APPR
- Product code
- MHY
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- APPROVAL FOR THE CHANGES TO THE PATIENT PROGRAMMER AND PATIENT RECHARGE KIT USED FOR MEDTRONIC SPINAL CORD STIMULATION AND DEEP BRAIN STIMULATION.
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