PMA P030027S007
- Device
- CERAMIC TRANSCEND ARTICULATION SYSTEM
- Applicant
- Microport Orthopedics, Inc.
- PMA number
- P030027
- Supplement
- S007
- Product code
- MRA
- Decision date
- 2014-01-03
- Classification
- Prosthesis, Hip, Semi-constrained, Metal/ceramic/ceramic/metal, Cemented Or Uncemented
- Generic name
- Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
- Approval order statement
- APPROVAL FOR CHANGING THE INCOMING INSPECTION PROCESS OFCOMPONENTS FROM THE SUPPLIER.
Current openFDA PMA Record#
- Device
- CERAMIC TRANSCEND ARTICULATION SYSTEM
- Applicant
- Microport Orthopedics, Inc.
- PMA number
- P030027
- Supplement
- S007
- Product code
- MRA
- Generic name
- Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
- Decision date
- 2014-01-03
- Decision code
- APPR
- Date received
- 2013-04-26
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR CHANGING THE INCOMING INSPECTION PROCESS OFCOMPONENTS FROM THE SUPPLIER.