CERAMIC TRANSCEND ARTICULATION SYSTEM
FDA premarket approval P030027/S007 · decided 2014-01-03
Approval details
- PMA number
- P030027
- Supplement
- S007
- 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
- 2013-04-26
- Decision date
- 2014-01-03
- Days to decision
- 252 days
- Decision code
- APPR
- Product code
- MRA
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Arlington, TN
- Statement
- APPROVAL FOR CHANGING THE INCOMING INSPECTION PROCESS OFCOMPONENTS FROM THE SUPPLIER.
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