PMA P030022S023
- Device
- REFLECTION CERAMIC HIP SYSTEM
- Applicant
- Smith & Nephew, Inc.
- PMA number
- P030022
- Supplement
- S023
- Product code
- MRA
- Decision date
- 2013-08-01
- 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 TWO CHANGES MADE BY AT A RAW MATERIAL SUPPLIER: 1) THE FORGING PROCESS OF THE R3 ACETABULAR SHELLS; AND 2) THE BLAST MEDIA USED FOR AN IN PROCESS BLAST OPERATION FOR THE SYNERGY FEMORAL STEMS.
Current openFDA PMA Record#
- Device
- REFLECTION CERAMIC HIP SYSTEM
- Applicant
- Smith & Nephew, Inc.
- PMA number
- P030022
- Supplement
- S023
- Product code
- MRA
- Generic name
- Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
- Decision date
- 2013-08-01
- Decision code
- APPR
- Date received
- 2013-02-19
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR TWO CHANGES MADE BY AT A RAW MATERIAL SUPPLIER: 1) THE FORGING PROCESS OF THE R3 ACETABULAR SHELLS; AND 2) THE BLAST MEDIA USED FOR AN IN PROCESS BLAST OPERATION FOR THE SYNERGY FEMORAL STEMS.