|
Device | DEEP BRAIN STIMULATION THERAPY |
Generic Name | Stimulator, electrical, implanted, for parkinsonian tremor |
Applicant | MEDTRONIC Inc. 7000 CENTRAL AVENUE NE MINNEAPOLIS, MN 55432-3576 |
PMA Number | P960009 |
Supplement Number | S075 |
Date Received | 01/07/2010 |
Decision Date | 03/04/2010 |
Product Code |
MHY |
Advisory Committee |
Neurology |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL FOR THE REFORMULATION OF THE HOTMELT ADHESIVE USED FOR THE MEDTRONIC NEUROMODULATION STERILE BARRIER BLISTER PACKAGES. |
Post-Approval Study | Show Report Schedule and Study Progress |