|
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 | S211 |
Date Received | 11/17/2014 |
Decision Date | 11/04/2015 |
Product Code |
MHY |
Advisory Committee |
Neurology |
Supplement Type | Normal 180 Day 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 1) EXPANDED MRI CONDITIONS FOR MEDTRONIC DBS SYSTEMS; 2) UPDATES TO THE MODEL 37651 PATIENT RECHARGER SYSTEM;3) CLARIFICATIONS TO THE GUIDELINES FOR CONDUCTING CT SCANS ON DBS PATIENTS; 4) ADDITION OF SYMBOLS TO STERILE AND SHELF-BOX PACKAGE LABELS FOR SPECIFIED MODELS; AND (5) UPDATES TO PACKAGE CONFIGURATIONS FOR SPECIFIED MODELS. |
Post-Approval Study | Show Report Schedule and Study Progress |