Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the Original HDE to get an up-to-date view of this device. |
|
Trade Name | RECLAIM DBS THERAPY FOR OBSESSIVE COMPULSIVE DISORDER (OCD) SYSTEM |
Classification Name | stimulator, brain, implanted, for behavior modification |
Generic Name | stimulator, brain, implanted, for behavior modification |
Applicant |
MEDTRONIC INC.,NEUROLOGICAL DIVISION |
7000 central avenue northeast |
minneapolis, MN 55432 |
|
HDE Number | H050003 |
Supplement Number | S100 |
Date Received | 02/18/2015 |
Decision Date | 03/20/2015 |
Product Code | |
Advisory Committee |
Neurology |
Supplement Type | 30-day notice |
Supplement Reason | process change - manufacturer/sterilizer/packager/supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Addition of an alternate material and component supplier. |
|
|