PMA P050039S002

Device
EXACTECH NOVATION CERAMIC AHS ARTICULATION HIP SYSTEM
Applicant
Exactech, Inc.
PMA number
P050039
Supplement
S002
Product code
MRA
Decision date
2008-11-19
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 A NEW RAW MATERIAL SUPPLIER.

Current openFDA PMA Record#

Device
EXACTECH NOVATION CERAMIC AHS ARTICULATION HIP SYSTEM
Applicant
Exactech, Inc.
PMA number
P050039
Supplement
S002
Product code
MRA
Generic name
Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
Decision date
2008-11-19
Decision code
APPR
Date received
2008-07-31
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 A NEW RAW MATERIAL SUPPLIER.