CERAMTEC CERAMIC TRANSCEND HIP ARTICULATION SYSTEM
FDA premarket approval P010001/S007 · decided 2010-09-15
Approval details
- PMA number
- P010001
- Supplement
- S007
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- CERAMTEC CERAMIC TRANSCEND HIP ARTICULATION SYSTEM
- Generic name
- Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
- Applicant
- Ceramtec GmbH
- Date received
- 2010-04-21
- Decision date
- 2010-09-15
- Days to decision
- 147 days
- Decision code
- APPR
- Product code
- MRA
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Plochingen
- Statement
- APPROVAL FOR THE REPLACEMENT OF TWO GRINDING MACHINES AND ADDITION OF ONE PIECE OF PROOF TESTING EQUIPMENT AT THE PLOCHINGEN, GERMANY FACILITY AND ADDITION OF A GRINDING MACHINE AND PIECE OF PROOF TESTING EQUIPMENT AT THE MARKTREDWITZ, GERMANY FACILITY.
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