|
Device | PINNACLE COMPLETE ACETABULAR HIP SYSTEM |
Generic Name | Prosthesis, hip, semi-constrained, ceramic-on-metal articulation |
Applicant | DEPUY ORTHOPAEDICS, INC. P.O BOX 988 700 ORTHOPAEDIC DRIVE WARSAW, IN 46581-0988 |
PMA Number | P090002 |
Supplement Number | S009 |
Date Received | 03/12/2013 |
Decision Date | 08/06/2013 |
Withdrawal Date
|
09/05/2013 |
Product Code |
OVO |
Advisory Committee |
Orthopedic |
Supplement Type | 135 Review Track For 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR CHANGES TO THE PROCESS PARAMETERS FOR AN EXISTING PACKAGE SEALER AND ADDITION OF AN ALTERNATE PACKAGE SEALER. |