|
Trade Name | Reclaim DBS Therapy for Obsessive Compulsive Disorder (OCD) System |
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 | S257 |
Date Received | 12/18/2020 |
Decision Date | 01/15/2021 |
Product Code | |
Advisory Committee |
Neurology |
Supplement Type | special (immediate track) |
Supplement Reason | process change - manufacturer/sterilizer/packager/supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement The center for devices and radiological health (cdrh) of the food and drug administration (fda) has completed its review of your premarket approval application (pma) supplement, which requested approval for use of a screening tool to screen/filter out a list of invalid hybrid serial numbers from the next available 1,048,564 serial numbers. The resulting invalid hybrid serial numbers are to be programmed into your factoryworks table to prevent them from being used for future hybrid manufacturing builds. |