MODEL 640011X4 POCKET ADAPTOR FOR DEEP BRAIN STIMULATION;MODEL 64002 2X4 POCKET ADAPTOR FOR DEEP BRAIN STIMULATION
FDA premarket approval P960009/S144 · decided 2012-05-30
Approval details
- PMA number
- P960009
- Supplement
- S144
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- MODEL 640011X4 POCKET ADAPTOR FOR DEEP BRAIN STIMULATION;MODEL 64002 2X4 POCKET ADAPTOR FOR DEEP BRAIN STIMULATION
- Generic name
- Stimulator, electrical, implanted, for parkinsonian tremor
- Applicant
- Medtronic, Inc.
- Date received
- 2012-04-30
- Decision date
- 2012-05-30
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- MHY
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- TIGHTEN THE ACCEPTANCE CRITERIA FOR THE TITANIUM CONTENT OF THE UN-INSULATED WIRE AND QUALIFY AN ALTERNATE SUPPLIER OF THE ETHYLENE TETRA-FLUORO-ETHYLENE (ETFE) MICRO-EXTRUSION PROCESS.
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510(k) clearances by this applicant
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| Concerto Versa™ Detachable Coil (K253511) | Medtronic, Inc. | 2026-01-14 |
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