PMA P050009S004

Device: C2A-TAPER ACETABULAR SYSTEM
Applicant: Biomet, Inc.
PMA number: P050009
Supplement: S004
Product code: MRA
Decision date: 2009-04-17
Generic name: Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
Approval order statement: APPROVAL FOR A CHANGE IN THE MATERIAL OF THE INNER POUCH WHICH HOLDS THE STERILE POROUS HIP CUPS, INCLUDING COMPONENTS OF THE DEVICE.

Current openFDA PMA Record#

Device: C2A-TAPER ACETABULAR SYSTEM
Applicant: Biomet, Inc.
PMA number: P050009
Supplement: S004
Product code: MRA
Generic name: Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
Decision date: 2009-04-17
Decision code: APPR
Date received: 2007-09-27
Supplement type: 135 Review Track For 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: APPROVAL FOR A CHANGE IN THE MATERIAL OF THE INNER POUCH WHICH HOLDS THE STERILE POROUS HIP CUPS, INCLUDING COMPONENTS OF THE DEVICE.