|
Trade Name | MEDTRONIC (ACTIVA)DEEP BRAIN STIMULATION FOR OCD THERAPY |
Classification Name | deep brain stimulator for obsessive compulsive disorder (ocd) |
Generic Name | deep brain stimulator for obsessive compulsive disorder (ocd) |
Applicant |
MEDTRONIC INC.,NEUROLOGICAL DIVISION |
7000 central avenue northeast |
minneapolis, MN 55432 |
|
HDE Number | H050003 |
Supplement Number | S146 |
Date Received | 01/13/2017 |
Decision Date | 02/06/2017 |
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 alternate supplier and manufacturing method for connector and electrodes used in quadripolar leads. |