C2A-TAPER ACETABULAR SYSTEM
FDA premarket approval P050009/S004 · decided 2009-04-17
Approval details
- PMA number
- P050009
- Supplement
- S004
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- C2A-TAPER ACETABULAR SYSTEM
- Generic name
- Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
- Applicant
- Biomet, Inc.
- Date received
- 2007-09-27
- Decision date
- 2009-04-17
- Days to decision
- 568 days
- Decision code
- APPR
- Product code
- MRA
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Warsaw, IN
- Statement
- APPROVAL FOR A CHANGE IN THE MATERIAL OF THE INNER POUCH WHICH HOLDS THE STERILE POROUS HIP CUPS, INCLUDING COMPONENTS OF THE DEVICE.
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