|Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.|
|1240 elko drive|
|sunnyvale, CA 94089|
|Supplement Type||normal 180 day track|
|Supplement Reason|| process change - manufacturer/sterilizer/packager/supplier|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for a contract packaging site located at biotecnica continental sa de cv, libramiento oriente 124-c, tijuana, bc 22490, mexico.