CERAMIC TRANSCEND ARTICULATION SYSTEM
FDA premarket approval P030027/S006 · decided 2013-06-20
Approval details
- PMA number
- P030027
- Supplement
- S006
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- CERAMIC TRANSCEND ARTICULATION SYSTEM
- Generic name
- Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
- Applicant
- Microport Orthopedics, Inc.
- Date received
- 2013-01-22
- Decision date
- 2013-06-20
- Days to decision
- 149 days
- Decision code
- APPR
- Product code
- MRA
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Arlington, TN
- Statement
- APPROVAL TO REPLACE MANUAL WASHING OF CERAMIC COMPONENTS WITH AN AUTOMATED WASHER.
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