| Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
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| Device | MEDTRONIC ACTIVA PARKINSON'S CONTROL SYSTEM |
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| Generic Name | Stimulator, electrical, implanted, for parkinsonian symptoms |
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| Applicant | MEDTRONIC Inc.
7000 CENTRAL AVENUE NE
MINNEAPOLIS, MN 55432-3576 |
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| PMA Number | P960009 |
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| Supplement Number | S007 |
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| Date Received | 09/30/1999 |
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| Decision Date | 01/14/2002 |
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| Product Code |
NHL |
| Docket Number | 02M-0217 |
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| Notice Date | 05/13/2002 |
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| Advisory Committee |
Neurology |
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| Supplement Type | Panel Track |
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| Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
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| Expedited Review Granted? | No |
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| Combination Product | No |
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| Recalls | CDRH Recalls |
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Approval Order Statement
APPROVAL FOR THE MEDTRONIC ACTIVA PARKINSON'S CONTROL THERAPY WHICH INCLUDES THE MODEL 3387 DBS LEAD, MODEL 3389 DBS LEAD, MODEL 7482 EXTENSION, MODEL 7495 EXTENSION, MODEL 7426 SOLETRA NEUROSTIMULATOR, BURR HOLE RING AND CAP, MODEL 7432 PHYSICIAN PROGRAMMER, MODEL 7460 MEMORYMOD SOFTWARE CARTRIDGE, MODEL 7452 PATIENT MAGNET, MODEL 3625 TEST STIMULATOR, MODEL 3353/3354 LEAD FRAME KIT, AND ACCESSORIES. THE DEVICE IS INDICATED FOR BILATERAL STIMULATION OF THE INTERNAL GLOBUS PALLIDUS (GPI) OR THE SUBTHALAMIC NUCLEUS (STN) AS AN ADJUNCTIVE THERAPY IN REDUCING SOME OF THE SYMPTOMS OF ADVANCED, LEVODOPA-RESPONSIVE PARKINSON'S DISEASE THAT ARE NOT ADEQUATELY CONTROLLED WITH MEDICATION. |
| Approval Order | Approval Order |
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| Summary | Summary of Safety and Effectiveness |
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| Labeling | Labeling
Labeling Part 2 |
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| Post-Approval Study | Show Report Schedule and Study Progress |
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