PMA P050009S002

Device: C2A-TAPER ACETABULAR SYSTEM
Applicant: Biomet, Inc.
PMA number: P050009
Supplement: S002
Product code: MRA
Decision date: 2006-06-16
Generic name: Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
Approval order statement: REPLACEMENT OF THE PREVIOUS SOFTWARE SYSTEM WITH AN IMAGE ANALYZER SOFTWARE AND THE REVISION OF THE POROUS COATING TEST PROCEDURES.

Current openFDA PMA Record#

Device: C2A-TAPER ACETABULAR SYSTEM
Applicant: Biomet, Inc.
PMA number: P050009
Supplement: S002
Product code: MRA
Generic name: Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
Decision date: 2006-06-16
Decision code: OK30
Date received: 2006-05-19
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: REPLACEMENT OF THE PREVIOUS SOFTWARE SYSTEM WITH AN IMAGE ANALYZER SOFTWARE AND THE REVISION OF THE POROUS COATING TEST PROCEDURES.