|
Device | STELKAST SURPASS ACETABULAR SYSTEM |
Generic Name | Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented |
Applicant | STELKAST COMPANY 200 HIDDEN VALLEY ROAD MCMURRAY, PA 15317 |
PMA Number | P040051 |
Supplement Number | S002 |
Date Received | 10/06/2009 |
Decision Date | 04/22/2011 |
Withdrawal Date
|
05/12/2016 |
Product Code |
MRA |
Advisory Committee |
Orthopedic |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Postapproval Study Protocol - OSB |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL. |