CERAMIC TRANSCEND HIP ARTICULATION
FDA premarket approval P030027/S009 · decided 2016-09-01
Approval details
- PMA number
- P030027
- Supplement
- S009
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- CERAMIC TRANSCEND HIP ARTICULATION
- Generic name
- Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
- Applicant
- Microport Orthopedics, Inc.
- Date received
- 2016-03-11
- Decision date
- 2016-09-01
- Days to decision
- 174 days
- Decision code
- APPR
- Product code
- MRA
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Arlington, TN
- Statement
- Approval for a manufacturing site located at Sterigenics US LLC, 1700 College Blvd, West Memphis, Arizona, 72301.
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