ACTIVA RC RECHARGEABLE IMPLANTABLE NEUROSTIMULATION SYSTEM
FDA premarket approval P960009/S051 · decided 2009-03-27
Approval details
- PMA number
- P960009
- Supplement
- S051
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- ACTIVA RC RECHARGEABLE IMPLANTABLE NEUROSTIMULATION SYSTEM
- Generic name
- Stimulator, electrical, implanted, for parkinsonian tremor
- Applicant
- Medtronic, Inc.
- Date received
- 2008-04-24
- Decision date
- 2009-03-27
- Days to decision
- 337 days
- Decision code
- APPR
- Product code
- MHY
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- APPROVAL FOR THE FOLLOWING NEW COMPONENTS AND ACCESSORIES FOR THE ACTIVA RCRECHARGEABLE IMPLANTABLE NEUROSTIMULATION SYSTEM:¿ ACTIVA RC, MODEL 37612 (NEUROSTIMULATOR)¿ PATIENT PROGRAMMER, MODEL 37642¿ MODEL 8870 APPLICATION CARD (ACTIVA RC)¿ EXTERNAL NEUROSTIMULATOR, MODEL 37022¿ 8-4 EXTENSION, MODEL 37085¿ ALLIGATOR CLIP SCREENING CABLE. MODEL 3550-67¿ TWIST LOCK SCREENING CABLE, MODEL 3550-68THE ACTIVA RC RECHARGEABLE IMPLANTABLE NEUROSTIMULATION SYSTEM IS INDICATED AS FOLLOWS:MEDTRONIC ACTIVA
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510(k) clearances by this applicant
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