MEDTRONIC ACTIVA DEEP BRAIN STIMULATION (DBS) SYSTEMS MODELS 3387S, 3389S DBS LEADS
FDA premarket approval P960009/S036 · decided 2006-03-02
Approval details
- PMA number
- P960009
- Supplement
- S036
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- MEDTRONIC ACTIVA DEEP BRAIN STIMULATION (DBS) SYSTEMS MODELS 3387S, 3389S DBS LEADS
- Generic name
- Stimulator, electrical, implanted, for parkinsonian tremor
- Applicant
- Medtronic, Inc.
- Date received
- 2005-12-28
- Decision date
- 2006-03-02
- Days to decision
- 64 days
- Decision code
- APPR
- Product code
- MHY
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- APPROVAL FOR MODIFICATIONS TO THE MODEL 3387/3398 DBS LEAD KIT INTENDED FOR USE WITH THE MEDTRONIC IMPLANTABLE SYSTEMS FOR DBS. THE MODIFICATIONS SPECIFIED WERE: TO REMOVE THE PERCUTANEOUS EXTENSION, TO ADD A LEAD CAP, AND TO BUNDLE THE MEDTRONIC IMAGE-GUIDED NEUROLOGICS STIMLOC KIT (BURR HOLE COVER ASSEMBLY) WITH THE DBS LEAD KIT.
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