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 | S012 |
Date Received | 09/09/2015 |
Decision Date | 05/03/2016 |
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 located at Ototronix LLC, 5000 Township Parkway, St. Paul, Minnesota to perform manufacturing and distribution. |
|
|