|
Device | ACTIVA TREMOR CONTROL THERAPY SYSTEM |
Generic Name | Stimulator, electrical, implanted, for parkinsonian tremor |
Applicant | MEDTRONIC Inc. 7000 CENTRAL AVENUE NE MINNEAPOLIS, MN 55432-3576 |
PMA Number | P960009 |
Supplement Number | S020 |
Date Received | 07/10/2001 |
Decision Date | 08/10/2001 |
Product Code |
MHY |
Advisory Committee |
Neurology |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR THE ADDITION OF AN ADDITIONAL QUALITY CONTOROL PROCESS STEP TO VERIFY THAT NEUROSTIMULATORS ARE MANUFACTURED TO THEIR SPECIFICATION, E.G., THE NEUROSTIMULATOR HAS THE SPECIFIED INSULATION BETWEEN THE BATTERY AND THE INTERNAL SURFACE OF THE TITANIUM CASE (SHIELD). |