Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
|
Device | MEDTRONIC NEUROMODULATION DEEP BRAIN STIMULATION SYSTEMS |
Generic Name | Stimulator, electrical, implanted, for parkinsonian tremor |
Applicant | MEDTRONIC Inc. 7000 CENTRAL AVENUE NE MINNEAPOLIS, MN 55432-3576 |
PMA Number | P960009 |
Supplement Number | S073 |
Date Received | 12/03/2009 |
Decision Date | 06/01/2010 |
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 |
Approval Order Statement APPROVAL FOR REVISED LABELING FOR THE DEVICE. THE CHANGES CONSIST OF ORGANIZATION, EDITORIAL, AND CONTENT REVISIONS, WHICH INCLUDE THE ADDITION OF NEW WARNINGS AND CONTRAINDICATIONS. |
|
|