MEDTRONIC MODEL 7482 DBS EXTENSION
FDA premarket approval P960009/S026 · decided 2002-10-31
Approval details
- PMA number
- P960009
- Supplement
- S026
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- MEDTRONIC MODEL 7482 DBS EXTENSION
- Generic name
- Stimulator, electrical, implanted, for parkinsonian tremor
- Applicant
- Medtronic, Inc.
- Date received
- 2002-07-15
- Decision date
- 2002-10-31
- Days to decision
- 108 days
- Decision code
- APPR
- Product code
- MHY
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- APPROVAL FOR THE FOLLOWING CHANGES TO THE APPROVED MODEL 7482 DBS EXTENSION; COMBINE LOW PROFILE DESIGN AND TECHNOLOGY WITH A LOW IMPEDANCE CONDUCTOR, CHANGE THE COATING USED ON THE OUTSIDE DIAMETER TO SILOXANE, ADD A NEW TORQUE WRENCH TO THE EXTENSION PACKAGE, AND ADD A NEW MODEL 3550-25 BOOTS ACCESSORY KIT.
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