DEEP BRAIN STIMULATION FAMILY OF NEUROSTIMULATION LEADS
FDA premarket approval P960009/S070 · decided 2009-10-15
Approval details
- PMA number
- P960009
- Supplement
- S070
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- DEEP BRAIN STIMULATION FAMILY OF NEUROSTIMULATION LEADS
- Generic name
- Stimulator, electrical, implanted, for parkinsonian tremor
- Applicant
- Medtronic, Inc.
- Date received
- 2009-08-24
- Decision date
- 2009-10-15
- Days to decision
- 52 days
- Decision code
- APPR
- Product code
- MHY
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- APPROVAL FOR AN ALTERNATE MANUFACTURING SITE LOCATED AT BENCHMARK ELECTRONICS, INC., WINONA, MINNESOTA FOR THE MANUFACTURE OF THE MEDTRONIC MODEL 3625 TEST STIMULATOR.
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