C2A-TAPER ACETABULAR HIP SYSTEM
FDA premarket approval P050009/S009 · decided 2011-02-11
Approval details
- PMA number
- P050009
- Supplement
- S009
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol - OSB
- Trade name
- C2A-TAPER ACETABULAR HIP SYSTEM
- Generic name
- Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
- Applicant
- Biomet, Inc.
- Date received
- 2010-02-16
- Decision date
- 2011-02-11
- Days to decision
- 360 days
- Decision code
- APPR
- Product code
- MRA
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Warsaw, IN
- Statement
- APPROVAL TO SUSPEND THE POST APPROVAL STUDY BASED ON SUSPENSION OF MARKETING AND SALES IN THE US.
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