Ceramic Transcend® Hip Articulation System
FDA premarket approval P030027/S005 · decided 2018-02-16
Approval details
- PMA number
- P030027
- Supplement
- S005
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - PAS
- Trade name
- Ceramic Transcend® Hip Articulation System
- Generic name
- Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
- Applicant
- Microport Orthopedics, Inc.
- Date received
- 2012-02-08
- Decision date
- 2018-02-16
- Days to decision
- 2200 days
- Decision code
- APPR
- Product code
- MRA
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Arlington, TN
- Statement
- Approval of product labeling which was updated after the completion of post-approval study protocol.
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