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 ACTIVA DEEP BRAIN STIMULATION (DBS) SYSTEMS MODELS 3387S, 3389S DBS 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 | S036 |
Date Received | 12/28/2005 |
Decision Date | 03/02/2006 |
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 MODIFICATIONS TO THE MODEL 3387/3398 DBS LEAD KIT INTENDED FOR USE WITH THE MEDTRONIC IMPLANTABLE SYSTEMS FOR DBS. THE MODIFICATIONS SPECIFIED WERE: TO REMOVE THE PERCUTANEOUS EXTENSION, TO ADD A LEAD CAP, AND TO BUNDLE THE MEDTRONIC IMAGE-GUIDED NEUROLOGICS STIMLOC KIT (BURR HOLE COVER ASSEMBLY) WITH THE DBS LEAD KIT. |
|
|