|
Device | ACTIVA DEEP BRAIN STIMULATION 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 | S230 |
Date Received | 05/28/2015 |
Decision Date | 06/26/2015 |
Product Codes |
MHY NHL |
Advisory Committee |
Neurology |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL FOR CHANGES TO THE USER MANUAL FOR THE IMPLANTABLE NEUROSTIMULATOR RECHARGING SYSTEMS; SPECIFICALLY, THE ADDITION OF A WARNING STATEMENT FOR THE ANTENNA LOCATE FEATURE, AS WELL AS INSTRUCTIONS FOR EXITING THIS FEATURE, AND DIRECTIONS TO CONTACT MEDTRONIC IF THE PATIENT ENCOUNTERS ANY PROBLEMS. |
Post-Approval Study | Show Report Schedule and Study Progress |