PMA P030027S004

Device
CERAMIC TRANSCEND ARTICULATION SYSTEM
Applicant
Microport Orthopedics, Inc.
PMA number
P030027
Supplement
S004
Product code
MRA
Decision date
2008-05-08
Classification
Prosthesis, Hip, Semi-constrained, Metal/ceramic/ceramic/metal, Cemented Or Uncemented
Generic name
Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
Approval order statement
APPROVAL FOR THE ADDITION OF AN AUTOMATED PROCESS TO SPECIFIC POLISHING STATIONS.

Current openFDA PMA Record#

Device
CERAMIC TRANSCEND ARTICULATION SYSTEM
Applicant
Microport Orthopedics, Inc.
PMA number
P030027
Supplement
S004
Product code
MRA
Generic name
Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
Decision date
2008-05-08
Decision code
APPR
Date received
2007-12-28
Supplement type
135 Review Track For 30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
APPROVAL FOR THE ADDITION OF AN AUTOMATED PROCESS TO SPECIFIC POLISHING STATIONS.