MEDTRONIC ACTIVA TREMOR CONTROL SYSTEM
FDA premarket approval P960009 · decided 1997-07-31
Approval details
- PMA number
- P960009
- Trade name
- MEDTRONIC ACTIVA TREMOR CONTROL SYSTEM
- Generic name
- Stimulator, electrical, implanted, for parkinsonian tremor
- Applicant
- Medtronic, Inc.
- Date received
- 1996-05-01
- Decision date
- 1997-07-31
- Days to decision
- 456 days
- Decision code
- APPR
- Product code
- MHY
- Advisory committee
- Neurology
- Expedited review
- Yes
- Location
- Minneapolis, MN
- Statement
- APPROVAL FOR THE MEDTRONIC(R) ACTIVA(TM) TREMOR CONTROL SYSTEM WHICH INCLUDES THE MODEL 3387 DBS(TM) LEAD, MODEL 7495 EXTENSION, MODEL 7424 IMPLANTABLE PULSE GENERATOR (IPG), MODEL 7458 MEMORY MODULE, MODEL 7432 CONSOLE PROGRAMMER, BUR HOLE RING AND CAP, MODEL 7452 MAGNET, MODEL 3625 TEST STIMULATOR (SCREENER) AND MODEL 3353/3354 LEAD FRAME KITS AND ACCESSORIES. THIS DEVIC IS INDICATED FOR UNILATERAL THALAMIC STIMULATION FOR THE SUPPRESSION OF TREMOR IN THE UPPER EXTREMITY IN PATIENTS WHO ARE DI
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510(k) clearances by this applicant
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