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 | NOVATION CERAMIC ARTICULATION HIP SYSTEM |
Generic Name | Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented |
Applicant | EXACTECH, INC. 2320 N.W. 66TH CT. GAINESVILLE, FL 32653 |
PMA Number | P050039 |
Supplement Number | S019 |
Date Received | 06/24/2016 |
Decision Date | 07/21/2016 |
Withdrawal Date
|
12/31/2020 |
Product Code |
MRA |
Advisory Committee |
Orthopedic |
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 an extra sealer for the packaging process. The new equipment is intended for the sealing of packages for the acetabular liner and femoral head components and mating bone screw components used with the Exactech Novation Ceramic Articulation Hip System (AHS). |
|
|