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 | MAXUM SYSTEM |
Generic Name | Implant, hearing, active, middle ear, partially implanted |
Applicant | OTOTRONIX, LLC 26620 I-45 NORTH HOUSTON, TX 77386 |
PMA Number | P010023 |
Supplement Number | S005 |
Date Received | 07/27/2010 |
Decision Date | 09/10/2010 |
Product Code |
MPV |
Advisory Committee |
Ear Nose & Throat |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Location Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR A MANUFACTURING SITE CHANGE TO BIOTEST LABORATORIS, INC. IN MINNEAPOLIS, MINNESOTA. |
|
|