|
Device | DEEP BRAIN STIMULATION FAMILY OF NEUROSTIMULATION LEADS |
Generic Name | Stimulator, electrical, implanted, for parkinsonian tremor |
Applicant | MEDTRONIC Inc. 7000 CENTRAL AVENUE NE MINNEAPOLIS, MN 55432-3576 |
PMA Number | P960009 |
Supplement Number | S070 |
Date Received | 08/24/2009 |
Decision Date | 10/15/2009 |
Product Code |
MHY |
Advisory Committee |
Neurology |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Location Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL FOR AN ALTERNATE MANUFACTURING SITE LOCATED AT BENCHMARK ELECTRONICS, INC., WINONA, MINNESOTA FOR THE MANUFACTURE OF THE MEDTRONIC MODEL 3625 TEST STIMULATOR. |
Post-Approval Study | Show Report Schedule and Study Progress |